| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 10886982181770 | 294.767 | 294767 | 4.0MM/2.5MM SCHANZ SCREW 18MM THRD/65MM | LXT,KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE,APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | 2 | NA |
| 2 | 10886982195944 | 357.25 | 35725 | SLIDE HAMMER FOR HAMMER GUIDE | FZY | HAMMER, SURGICAL | 1 | NA |
| 3 | 10886982195920 | 357.221 | 357221 | FEMORAL NAIL HAMMER GUIDE | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | NA | |
| 4 | 10886982195913 | 357.22 | 35722 | HAMMER GUIDE FOR SLIDE HAMMER | FZY | HAMMER, SURGICAL | NA | |
| 5 | 10886982195906 | 357.181 | 357181 | FEMORAL NAIL DRIVING ADAPTOR | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | NA | |
| 6 | 10886982195883 | 357.133 | 357133 | EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS | HWB | EXTRACTOR | 1 | NA |
| 7 | 10886982195876 | 357.128 | 357128 | 13.0MM/3.2MM TROCAR | FZX | Guide, surgical, instrument | 1 | NA |
| 8 | 10886982195357 | 356.309 | 356309 | 9MM TREPHINE | HWK | TREPHINE | 1 | NA |
| 9 | 10886982195869 | 357.127 | 357127 | 13.0MM PROTECTION SLEEVE | FZX | Guide, surgical, instrument | 1 | NA |
| 10 | 10886982195791 | 357.096 | 357096 | AIMING ARM FOR 6.0MM TI LOCKING SCREWS | FZX | Guide, surgical, instrument | NA | |
| 11 | 10886982195784 | 357.095 | 357095 | CONNECTING SCREW FOR TI DISTAL FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
| 12 | 10886982195777 | 357.073 | 357073 | EXTRACTION HOLDING SLEEVE FOR HIP PIN | FZX | Guide, surgical, instrument | 1 | NA |
| 13 | 10886982195753 | 357.055 | 357055 | SCREWDRIVER HEXAGONAL CANNULATED L365MM | HXX | SCREWDRIVER | 1 | NA |
| 14 | 10886982195746 | 357.054 | 357054 | T-HANDLE | HXC | WRENCH | 1 | NA |
| 15 | 10886982195739 | 357.052 | 357052 | TROCHANTERIC FIXATION NAIL SCREW COMPRESSION NUT | HWC,HSB | Screw, fixation, bone,ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | NA | |
| 16 | 10886982195722 | 357.051 | 357051 | COUPLING SCREW | HXC | WRENCH | 1 | NA |
| 17 | 10886982195715 | 357.047 | 357047 | 6.5MM CANNULATED DRILL BIT QC/330MM | HTW | BIT, DRILL | 1 | NA |
| 18 | 10886982195708 | 357.046 | 357046 | FIXATION SLEEVE | HTW,FZX | BIT, DRILL,Guide, surgical, instrument | 1 | NA |
| 19 | 10886982195692 | 357.039 | 357039 | 2.8MM GUIDE WIRE 350MM | JDW,JDS | PIN, FIXATION, THREADED,NAIL, FIXATION, BONE | 2 | NA |
| 20 | 10886982195685 | 356.982 | 356982 | 4.0MM THREE-FLUTED DRILL BIT QC/215MM/80MM CALIB | GFF,HSZ,HWE,GFA | BUR, SURGICAL, GENERAL & PLASTIC SURGERY,Instrument, surgical, orthopedic, pneum BUR, SURGICAL, GENERAL & PLASTIC SURGERY,Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment,INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT,BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | 1 | NA |
| 21 | 10886982195678 | 356.98 | 35698 | 4.0MM THREE-FLUTED DRILL BIT QC/270MM/95MM CALIB | GFF,HWE,GFA,HSZ | BUR, SURGICAL, GENERAL & PLASTIC SURGERY,INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-PO BUR, SURGICAL, GENERAL & PLASTIC SURGERY,INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT,BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL,Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment | 1 | NA |
| 22 | 10886982195654 | 356.972 | 356972 | 3.2MM THREE-FLUTED DRILL BIT QC/215MM/82MM CALIBRATION | HTW | BIT, DRILL | 1 | NA |
| 23 | 10886982195647 | 356.97 | 35697 | 3.2MM THREE-FLUTED DRILL BIT QC/215MM/80MM CALIB | HTW | BIT, DRILL | 1 | NA |
| 24 | 10886982195623 | 356.830 | 356830 | GUIDE WIRE 3.2MM FOR PFNA BLADE | FZX | Guide, surgical, instrument | 1 | NA |
| 25 | 10886982195616 | 356.825 | 356825 | EXTRACTION SCREW FOR PFNA BLADE | HWB | EXTRACTOR | 1 | NA |
| 26 | 10886982195609 | 356.717 | 356717 | GUIDE WIRE 2.8MM LENGTH 460MM WITH HOOK | HWB | EXTRACTOR | 1 | NA |
| 27 | 10886982195517 | 356.544 | 356544 | INSERTION BOLT FOR TI CANNULATED TIBIAL NAIL | FZX | Guide, surgical, instrument | 1 | NA |
| 28 | 10886982195500 | 356.543 | 356543 | EXTRACTION SCREW FOR TITANIUM TIBIAL NAIL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
| 29 | 10886982195494 | 356.542 | 356542 | INSERTION BOLT FOR SOLID TIBIAL NAIL | FZX | Guide, surgical, instrument | 1 | NA |
| 30 | 10886982195463 | 356.49 | 35649 | INSERTER-EXTRACTOR FOR TI TIBIAL & HUMERAL NAILS | HWB | EXTRACTOR | 1 | NA |
| 31 | 10886982195456 | 356.350 | 356350 | RATCHET GRIP | HWB | EXTRACTOR | 1 | NA |
| 32 | 10886982195449 | 356.340 | 356340 | DRIVE SHAFT 490MM | HWB | EXTRACTOR | 1 | NA |
| 33 | 10886982195432 | 356.332 | 356332 | EXTRACTOR HEAD F/12MM NAILS | HWB | EXTRACTOR | 1 | NA |
| 34 | 10886982195425 | 356.331 | 356331 | EXTRACTOR HEAD F/11MM NAILS | HWB | EXTRACTOR | 1 | NA |
| 35 | 10886982195418 | 356.330 | 356330 | EXTRACTOR HEAD F/10MM NAILS | HWB | EXTRACTOR | 1 | NA |
| 36 | 10886982195401 | 356.329 | 356329 | EXTRACTOR HEAD F/9MM NAILS | HWB | EXTRACTOR | 1 | NA |
| 37 | 10886982195395 | 356.328 | 356328 | EXTRACTOR HEAD F/8MM NAILS | HWB | EXTRACTOR | 1 | NA |
| 38 | 10886982195388 | 356.312 | 356312 | 12MM TREPHINE | HWK | TREPHINE | 1 | NA |
| 39 | 10886982195371 | 356.311 | 356311 | 11MM TREPHINE | HWK | TREPHINE | 1 | NA |
| 40 | 10886982195364 | 356.310 | 356310 | 10MM TREPHINE | HWK | TREPHINE | 1 | NA |
| 41 | 10886982195234 | 355.89 | 35589 | 6.0MM/5.0MM DRILL SLEEVE | FZX | Guide, surgical, instrument | 1 | NA |
| 42 | 10886982195227 | 355.88 | 35588 | 5.0MM/3.5MM DRILL SLEEVE | FZX | Guide, surgical, instrument | 1 | NA |
| 43 | 10886982195210 | 355.87 | 35587 | 3.5MM TROCAR | FZX | Guide, surgical, instrument | 1 | NA |
| 44 | 10886982195203 | 355.75 | 35575 | 8.0MM TROCAR | FZX | Guide, surgical, instrument | 1 | NA |
| 45 | 10886982195081 | 355.59 | 35559 | LOCKING NUT FOR 17MM-19MM UNIVERSAL FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
| 46 | 10886982195074 | 355.58 | 35558 | LOCKING NUT FOR 13MM-16MM UNIVERSAL FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
| 47 | 10886982195067 | 355.57 | 35557 | LOCKING NUT FOR 9MM-12MM UNIVERSAL FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
| 48 | 10886982195050 | 355.55 | 35555 | THREADED CONICAL BOLT FOR 17MM-19MM UNIV FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
| 49 | 10886982195043 | 355.54 | 35554 | THREADED CONICAL BOLT FOR 13MM-16MM UNIV FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
| 50 | 10886982195036 | 355.53 | 35553 | THREADED CONICAL BOLT FOR 9MM-12MM UNIV FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
| 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 |