| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 10840199537119 | 8800-504 | 8800-504 | Tower Arm Clamp | GAD | Retractor | 1 | Tower Arm Clamp |
| 2 | 10840199511874 | 7316-85 | 7316-85 | Counter Blade 77x30mm | GAD | Retractor | 1 | Counter Blade |
| 3 | 10840199524805 | 7414-01 | 7414-01 | Long Micro Curette Down-Pusher Size 1 | FZS | Curette, Surgical, General Use | 1 | Curette |
| 4 | 10840199521682 | 7391-41 | 7391-41 | Black Offset Foramenotonmy Rongeur 4mm x 40 Degree, 9" | HTX | Rongeur | 1 | Foramenotomy Rongeur |
| 5 | 10840199539090 | 9109-00 | 9109-00 | Double Action Wire/Pin Cutter 2.5mm Max Wire Diameter 22cm 8-3/4" | HXZ | Cutter, Wire | 1 | Wire Cutter |
| 6 | 10840199539083 | 9108-00 | 9108-00 | Double Action Wire/Pin Cutter 1.7mm Max Wire Diameter 18.5cm 7-1/4" | HXZ | Cutter, Wire | 1 | Wire Cutter |
| 7 | 10840199539076 | 9107-00 | 9107-00 | Double Action Wire/Pin Cutter 2.8mm Max Wire Diameter 24cm 9-1/4" | HXZ | Cutter, Wire | 1 | Wire Cutter |
| 8 | 10840199539069 | 9106-00 | 9106-00 | Flush End & Side Wire Cutter 7.5mm Jaw 17cm 6-3/4" | HXZ | Cutter, Wire | 1 | Wire Cutter |
| 9 | 10840199539045 | 9100-18 | 9100-18 | Double Action Sternal Wire Cutter with Replaceabel Blades 18cm 7" | HXZ | Cutter, Wire | 1 | Wire Cutter |
| 10 | 10840199539038 | 9000-17 | 9000-17 | Long Wire Cutter Scissors w/ Serrated Tungsten Carbide Blades 15cm 6" | HXZ | Cutter, Wire | 1 | Wire Cutter |
| 11 | 10840199539021 | 8995-60 | 8995-60 | Large Blades 2.5 x 2.5" Wide | GAD | Retractor | 1 | Blades |
| 12 | 10840199539014 | 8995-50 | 8995-50 | Medium Blades 2.5 x 1.5" wWde | GAD | Retractor | 1 | Blades |
| 13 | 10840199539007 | 8995-40 | 8995-40 | Small Blades 1.5 x 2" Wide | GAD | Retractor | 1 | Blades |
| 14 | 10840199538994 | 8995-30 | 8995-30 | Table Post w/ Cross Clamp | GAD | Retractor | 1 | Table Post |
| 15 | 10840199538758 | 8960-63 | 8960-63 | Circumflex Stabilizer Platform Left | GAD | Retractor | 1 | Circumflex Stabilizer Platform |
| 16 | 10840199538741 | 8960-62 | 8960-62 | Circumflex Stabilizer Platform, Right | GAD | Retractor | 1 | Circumflex Stabilizer Platform |
| 17 | 10840199538734 | 8960-61 | 8960-61 | U-Shaped Stabilizer Platform Left | GAD | Retractor | 1 | U-Shaped Stabilizer Platform |
| 18 | 10840199538727 | 8960-60 | 8960-60 | U-Shaped Stabilizer Platform Right | GAD | Retractor | 1 | U-Shaped Stabilizer Platform |
| 19 | 10840199538710 | 8960-52 | 8960-52 | Stabilizer Arm Curved | GAD | Retractor | 1 | Stabilizer Arm Curved |
| 20 | 10840199538680 | 8960-42 | 8960-42 | Valve Suture Bars | GAD | Retractor | 1 | Valve Suture Bars |
| 21 | 10840199538505 | 8955-10 | 8955-10 | InterChange Long Arm Retractor 22.5cm Arm 22cm Opening | GAD | Retractor | 1 | InterChange Long Arm Retractor |
| 22 | 10840199538420 | 8950-45 | 8950-45 | AVR Quick Blade Deep 45mm | GAD | Retractor | 1 | AVR Quick Blade |
| 23 | 10840199538413 | 8950-35 | 8950-35 | AVR Quick Blade Medium 35mm | GAD | Retractor | 1 | AVR Quick Blade |
| 24 | 10840199538406 | 8950-27 | 8950-27 | AVR Quick Blade Small 27mm | GAD | Retractor | 1 | AVR Quick Blade |
| 25 | 10840199538253 | 8920-30 | 8920-30 | IMA Support Tower w/Connecting Clamp | GAD | Retractor | 1 | IMA Support Tower |
| 26 | 10840199538130 | 8910-32 | 8910-32 | CAB Multi-Position Stabilizer Left w/Connecting Arm & Tower Clamp | GAD | Retractor | 1 | CAB Multi-Position Stabilizer |
| 27 | 10840199538123 | 8910-30 | 8910-30 | CAB Multi-Position Stabilizer Right w/Connecting Arm & Tower Clamp | GAD | Retractor | 1 | CAB Multi-Position Stabilizer |
| 28 | 10840199537935 | 8899-20 | 8899-20 | UniTrack Tower | GAD | Retractor | 1 | UniTrack Tower |
| 29 | 10840199537713 | 8897-20 | 8897-20 | Upper Frame Tower | GAD | Retractor | 1 | Upper Frame Tower |
| 30 | 10840199537669 | 8862-65 | 8862-65 | Low Profile Retractor Wide 27 x 10mm Deep | GAD | Retractor | 1 | Low Profile Retractor |
| 31 | 10840199537652 | 8862-64 | 8862-64 | Low Profile Retractor 17 x 17mm Deep | GAD | Retractor | 1 | Low Profile Retractor |
| 32 | 10840199537645 | 8862-55 | 8862-55 | Side Extension w/Clamp 50mm Long | GAD | Retractor | 1 | Side Extension |
| 33 | 10840199537522 | 8860-46 | 8860-46 | Aortic Valve Retractor 9mm Wide | GAD | Retractor | 1 | Valve Retractor |
| 34 | 10840199537515 | 8860-45 | 8860-45 | Tricuspid Valve Retractor 22mm Wide | GAD | Retractor | 1 | Valve Retractor |
| 35 | 10840199537478 | 8860-38 | 8860-38 | Side Extension w/Clamp 50mm Long | GAD | Retractor | 1 | Side Extension |
| 36 | 10840199537393 | 8840-05 | 8840-05 | Kruhana I.M.A. Claw Hand Retractor 20cm Long | GAD | Retractor | 1 | I.M.A. Claw Hand Retractor |
| 37 | 10840199537263 | 8800-570 | 8800-570 | Suture Boot Set Consisting of the Following: 1 x 8800-511 Short Suture Boot 3-1/ Suture Boot Set Consisting of the Following: 1 x 8800-511 Short Suture Boot 3-1/2" Long, 1 x 8800-512 Medium Suture Boot 6" Long & 1 x 8800-513 Long Suture Boot 7-1/4" Long | GAD | Retractor | 1 | Suture Boot Set |
| 38 | 10840199537218 | 8800-522 | 8800-522 | Universal Holding Bar w/Long Tower Clamp for 8800-80 | GAD | Retractor | 1 | Valve Retractor |
| 39 | 10840199537157 | 8800-508 | 8800-508 | Low Profile Valve Retractor 16 x 45mm | GAD | Retractor | 1 | Low Profile Valve Retractor |
| 40 | 10840199537140 | 8800-507 | 8800-507 | Large Valve Retractor 38 x 42mm | GAD | Retractor | 1 | Valve Retractor |
| 41 | 10840199537133 | 8800-506 | 8800-506 | Medium Valve Retractor 30 x 42mm | GAD | Retractor | 1 | Valve Retractor |
| 42 | 10840199536990 | 8798-20 | 8798-20 | Quick Change Tower Attachment w/Cross Bar for Stabilizer | GAD | Retractor | 1 | Quick Change Tower Attachment |
| 43 | 10840199536983 | 8798-19 | 8798-19 | Quick Change Tower Attachment w/Cross Bar for Valve | GAD | Retractor | 1 | Quick Change Tower Attachment |
| 44 | 10840199536433 | 8694-00 | 8694-00 | Frater Type Valve Retractor, 7 x 28mm Tip 195mm Length | GAD | Retractor | 1 | Valve Retractor |
| 45 | 10840199536426 | 8692-02 | 8692-02 | Minimal Invasive Extra Deep Valve Retractor, 3 x 18cm Tip 30cm Length | GAD | Retractor | 1 | Valve Retractor |
| 46 | 10840199536419 | 8692-00 | 8692-00 | Minimal Invasive Extra Deep Valve Retractor, 3 x 12.5cm Tip 30cm Length | GAD | Retractor | 1 | Valve Retractor |
| 47 | 10840199536051 | 8600-02 | 8600-02 | Premature Retractor | GAD | Retractor | 1 | Premature Retractor |
| 48 | 10840199535603 | 8300-05 | 8300-05 | Cardiovascular Spring Retractor Up Loop | GAD | Retractor | 1 | Spring Retractor |
| 49 | 10840199533500 | 7793-22 | 7793-22 | Spetzer Type Angled Ball Probe 40 Degree | FZS,KAK | Curette, Surgical, General Use,Probe, Ent | 1 | Ball Probe |
| 50 | 10840199533494 | 7793-21 | 7793-21 | Spetzer Type Angled Ball Probe 90 Degree | FZS,KAK | Curette, Surgical, General Use,Probe, Ent | 1 | Ball Probe |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B0994403130 | 440-313 | BAILEY RONGEUR | BAILEY AORTIC VALVE RONGEUR | SONTEC INSTRUMENTS, INC. | |
| 2 | B089B630150 | B63015 | B63015 | TEBBETTS RONGEUR; 6 1/4''(16CM) , 2.5MM JAW | N/A | BLACK & BLACK SURGICAL, INC. |
| 3 | B089B630100 | B63010 | B63010 | BEYER STAINLESS STEEL RONGEUR; 7''(18CM), 3MM JAW | N/A | BLACK & BLACK SURGICAL, INC. |
| 4 | B089B522180 | B52218 | B52218 | GORNEY ONYX MORSELIZERS; GUARD ONLY | N/A | BLACK & BLACK SURGICAL, INC. |
| 5 | B089B522170 | B52217 | B52217 | GORNEY ONYX MORSELIZERS; 8.0''(20CM), STRAIGHT | N/A | BLACK & BLACK SURGICAL, INC. |
| 6 | B089B522150 | B52215 | B52215 | GORNEY ONYX MORSELIZERS; 8''(20CM), ANGLED | N/A | BLACK & BLACK SURGICAL, INC. |
| 7 | B089B522130 | B52213 | B52213 | BERNSTEIN FORCEPS; SEPTAL, ARCHED, CARBIDE JAW, 8 1/4" (21CM) | N/A | BLACK & BLACK SURGICAL, INC. |
| 8 | B089B522110 | B52211 | B52211 | GUNTER ONYX MORSELIZERS; 7"(18CM), LONGITUDINAL JAW | N/A | BLACK & BLACK SURGICAL, INC. |
| 9 | B089B522100 | B52210 | B52210 | GUNTER ONYX MORSELIZERS; 7"(18CM) | N/A | BLACK & BLACK SURGICAL, INC. |
| 10 | B07319K0861500 | 19-K08-6150 | 19-K08-6150 | Pituitary, Up Biting, 3mm | Kalitec Disc Prep | KALITEC DIRECT LLC |
| 11 | B07319K0861400 | 19-K08-6140 | 19-K08-6140 | Pituitary, Straight, 3mm | Kalitec Disc Prep | KALITEC DIRECT LLC |
| 12 | B06217607081 | 1760-7081 | 1760-7081 | 8mm Sypert Rongeur, 335mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 13 | B06217607080 | 1760-7080 | 1760-7080 | 5mm Sypert Rongeur, 335mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 14 | B06217607079 | 1760-7079 | 1760-7079 | 6mm Pituitary Rongeur, Angled Down, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 15 | B06217607078 | 1760-7078 | 1760-7078 | 6mm Pituitary Rongeur, Angled Up, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 16 | B06217607077 | 1760-7077 | 1760-7077 | 6mm Pituitary Rongeur, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 17 | B06217607076 | 1760-7076 | 1760-7076 | 6mm Pituitary Rongeur, Angled Down, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 18 | B06217607075 | 1760-7075 | 1760-7075 | 6mm Pituitary Rongeur, Angled Up, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 19 | B06217607074 | 1760-7074 | 1760-7074 | 6mm Pituitary Rongeur, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 20 | B06217607073 | 1760-7073 | 1760-7073 | 6mm Kerrison Rongeur, Angled, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 21 | B06217607072 | 1760-7072 | 1760-7072 | 6mm Kerrison Rongeur, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 22 | B06217607071 | 1760-7071 | 1760-7071 | 6mm Kerrison Rongeur, Angled, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 23 | B06217607070 | 1760-7070 | 1760-7070 | 6mm Kerrison Rongeur, 350mmhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml# | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 24 | B06217607069 | 1760-7069 | 1760-7069 | 5mm Pituitary Rongeur, Angled Down, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 25 | B06217607067 | 1760-7067 | 1760-7067 | 5mm Pituitary Rongeur, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 26 | B06217607066 | 1760-7066 | 1760-7066 | 5mm Pituitary Rongeur, Angled Down, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 27 | B06217607065 | 1760-7065 | 1760-7065 | 5mm Pituitary Rongeur, Angled Up, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 28 | B06217607064 | 1760-7064 | 1760-7064 | 5mm Pituitary Rongeur, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 29 | B06217607063 | 1760-7063 | 1760-7063 | 5mm Kerrison Rongeur, Angled, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 30 | B06217607062 | 1760-7062 | 1760-7062 | 5mm Kerrison Rongeur, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 31 | B06217607061 | 1760-7061 | 1760-7061 | 5mm Kerrison Rongeur, Angled, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 32 | B06217607060 | 1760-7060 | 1760-7060 | 5mm Kerrison Rongeur, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 33 | B06217607059 | 1760-7059 | 1760-7059 | 4mm Pituitary Rongeur, Angled Down, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 34 | B06217607058 | 1760-7058 | 1760-7058 | 4mm Pituitary Rongeur, Angled Up, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 35 | B06217607057 | 1760-7057 | 1760-7057 | 4mm Pituitary Rongeur, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 36 | B06217607056 | 1760-7056 | 1760-7056 | 4mm Pituitary Rongeur, Angled Down, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 37 | B06217607055 | 1760-7055 | 1760-7055 | 4mm Pituitary Rongeur, Angled Up, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 38 | B06217607054 | 1760-7054 | 1760-7054 | 4mm Pituitary Rongeur, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 39 | B06217607053 | 1760-7053 | 1760-7053 | 4mm Kerrison Rongeur, Angled, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 40 | B06217607052 | 1760-7052 | 1760-7052 | 4mm Kerrison Rongeur, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 41 | B06217607051 | 1760-7051 | 1760-7051 | 4mm Kerrison Rongeur, Angled, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 42 | B06217607050 | 1760-7050 | 1760-7050 | 4mm Kerrison Rongeur, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 43 | B06217607049 | 1760-7049 | 1760-7049 | 3mm Pituitary Rongeur, Angled Down, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 44 | B06217607048 | 1760-7048 | 1760-7048 | 3mm Pituitary Rongeur, Angled Up, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 45 | B06217607047 | 1760-7047 | 1760-7047 | 3mm Pituitary Rongeur, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 46 | B06217607046 | 1760-7046 | 1760-7046 | 3mm Pituitary Rongeur, Angled Down, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 47 | B06217607045 | 1760-7045 | 1760-7045 | 3mm Ptuitary Rongeur, Angled Up, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 48 | B06217607044 | 1760-7044 | 1760-7044 | 3mm Ptuitary Rongeur, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 49 | B06217607043 | 1760-7043 | 1760-7043 | 3mm Kerrison Rongeur, Angled, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |
| 50 | B06217607042 | 1760-7042 | 1760-7042 | 3mm Kerrison Rongeur, Bayonetted, 350mm | Pisces-SA | OSSEUS FUSION SYSTEMS, LLC |