No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | B201CGCORE24MR0 | CGCORE24MR | CG-CORE24-MR | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally. | JAK | System, X-Ray, Tomography, Computed | Clear Guide CORE | |
2 | B201CGCORE240 | CGCORE24 | CG-CORE24 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen. | JAK | System, X-Ray, Tomography, Computed | Clear Guide CORE | |
3 | B201CGCORE170 | CGCORE17 | CG-CORE17 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE17 model is a panel PC with a 17" screen. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | Clear Guide CORE | |
4 | B201CGCORE130 | CGCORE13 | CG-CORE-13 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE13 model is a tablet PC with a 13" screen. | JAK | System, X-Ray, Tomography, Computed | Clear Guide CORE | |
5 | B201CGVMNS0 | CGVMNS | CG-VM-NS | The device is a sterile or sterilizable (via PVP-I or similar antiseptic) access The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. | JAC | System, X-Ray, Film Marking, Radiographic | Clear Guide VisiMARKER Non-Sterile | |
6 | B201CGSCENERGY0 | CGSCENERGY | JAK | System, X-Ray, Tomography, Computed | 2 | Clear Guide SCENERGY | ||
7 | B201CGVM2NS0 | CGVM2NS | CG-VM2-NS | The device is a sterile or sterilizable (via PVP-I or similar antiseptic) access The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. | JAC | System, X-Ray, Film Marking, Radiographic | Clear Guide VisiMARKER II Non-Sterile | |
8 | B201CGONE0 | CGONE | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Clear Guide ONE | ||
9 | B201CGVM20 | CGVM2 | CG-VM2 | The device is a sterile or sterilizable (via PVP-I or similar antiseptic) access The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. | JAC | System, X-Ray, Film Marking, Radiographic | Clear Guide VisiMARKER II | |
10 | B201CGVM0 | CGVM | The device is a sterile or sterilizable (via PVP-I or similar antiseptic) access The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. | JAC | System, X-Ray, Film Marking, Radiographic | Clear Guide VisiMARKER | ||
11 | B201CGSMM0 | CGSMM | CG-SM-M | The device is a sterile accessory intended to provide a sterile barrier for medi The device is a sterile accessory intended to provide a sterile barrier for medical procedures that require sterility and utilize the Clear Guide SuperPROBE (customer's ultrasound probe with Clear Guide Optical Head). The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. Device is packaged together with one sterile gel packet. | PUI | Drape, Surgical, Exempt | Clear Guide SteriMASK | |
12 | B201CGTT0 | CGTT | JAC | System, X-Ray, Film Marking, Radiographic | Clear Guide TipTAG | |||
13 | B201CGOHM0 | CGOHM | CG-OH-M | The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. | IYO,JAK | System, Imaging, Pulsed Echo, Ultrasonic,System, X-Ray, Tomography, Computed | Clear Guide Optical Head | |
14 | B201CGOH0 | CGOH | CG-OH | The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. | IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | Clear Guide Optical Head |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00841036242169 | WAL121 | WAL121 | WALTERLORENZ™ SURGICAL ASSIST ARM | BIOMET MICROFIXATION, INC | |
2 | 00841027100171 | 420-HE-S | 420-HE-S | One-Piece Drape, Heavy Duty, Sterile, for Big Case Back Table 429 | OR Specific | OR SPECIFIC, INC. |
3 | 00841027100157 | 419-HE-S | 419-HE-S | One-Piece Drape, Heavy Duty, Sterile, for Big Case Back Table 428 | OR Specific | OR SPECIFIC, INC. |
4 | 00841027100140 | 418-HE-S | 418-HE-S | One-Piece Drape, Heavy Duty, Sterile, for Big Case Back Table 427 | OR Specific | OR SPECIFIC, INC. |
5 | 00841027100133 | CDS-3072-EE | CDS-3072-EE | One-Piece Disposable Drape. Sterile, 12/case, for CDS-3072 6' | Pedigo Products, Inc. | PEDIGO PRODUCTS, INC. |
6 | 00841027100126 | CDS-3060-EE | CDS-3060-EE | One-Piece Disposable Drape. Sterile, 12/case, for CDS 3060 5' | Pedigo Products, Inc. | PEDIGO PRODUCTS, INC. |
7 | 00841027100089 | 419-HD-NS | 419-HD-NS | Drape, Heavy Duty, NonSterile. Fits 5' Big Case Back Table model | OR Specific | OR SPECIFIC, INC. |
8 | 00841027100072 | 420-S | 420-S | Drape, Standard, Sterile. For a 6' Big Case Back Table model 429 | OR Specific | OR SPECIFIC, INC. |
9 | 00841027100065 | 419-S | 419-S | Drape, Standard, Sterile. For a 5' Big Case Back Table model 428 | OR Specific | OR SPECIFIC, INC. |
10 | 00841027100058 | 418-S | 418-S | Drape, Heavy Duty, Sterile. For a 4' Big Case Back Table model 427 | OR Specific | OR SPECIFIC, INC. |
11 | 00841027100041 | 420-HD-S | 420-HD-S | Drape, Heavy duty, Sterile. For a 6' Big Case Back Table model 429 | OR Specific | OR SPECIFIC, INC. |
12 | 00841027100034 | 419-HD-S | 419-HD-S | Drape, Heavy Duty, Sterile. For a 5' Big Case Back Table model 428 | OR Specific | OR SPECIFIC, INC. |
13 | 00841027100027 | 418-HD-S | 418-HD-S | Drape, Heavy Duty, Sterile. For a 4' Big Case Back Table model 427 | OR Specific | OR SPECIFIC, INC. |
14 | 00841027100010 | CDS-3060-DD | CDS-3060-DD | Disposable Drape, sterile, for a CDS-3060 5 foot table | Pedigo Products, Inc. | PEDIGO PRODUCTS, INC. |
15 | 00841027100003 | CDS-3072-DD | CDS-3072-DD | Disposable Drape, sterile, for a CDS-3072 6 foot table | Pedigo Products, Inc. | PEDIGO PRODUCTS, INC. |
16 | 00840216114098 | PS3240 | O.R. Absorbent Floor Drape 32" x 40" | PRIMO/ASP MEDICAL | ASP GLOBAL, LLC | |
17 | 00840216114081 | PS1640 | O.R. Absorbent Floor Drape 16" x 40" | PRIMO/ASP MEDICAL | ASP GLOBAL, LLC | |
18 | 00840216114074 | PS1618 | O.R. Absorbent Floor Drape 16" x 18" | PRIMO/ASP MEDICAL | ASP GLOBAL, LLC | |
19 | 00840216108745 | DRAPE5670 | DRAPE, TRANSPARENT INTUBATION, 56"X70", AAMI LEVEL 2, 1" ADHESIVE CENTERED ON LO DRAPE, TRANSPARENT INTUBATION, 56"X70", AAMI LEVEL 2, 1" ADHESIVE CENTERED ON LONG SIDE OF DRAPE, 1EA/BG, 100BG/CS | ASP MEDICAL | ASP GLOBAL, LLC | |
20 | 00818566016614 | B8320W | B8320W | OR Towels Non-Sterile, 100 Bulk, White, 400/cs | PremierPro | SVS LLC |
21 | 00818566016607 | B8320G | B8320G | OR Towels Non-Sterile, 100 Bulk, Green, 400/cs | PremierPro | SVS LLC |
22 | 00818566016591 | B8320B | OR Towels Non-Sterile, 100 Bulk, Blue, 400/cs | PremierPro | SVS LLC | |
23 | 00818566013415 | B8310B | B8310B | PremierPro OR Towels, Non-Sterile, Bulk, Blue | PremierPro | SVS LLC |
24 | 00818566010995 | 8326W | 8326W | OR Towel, 17" x 26" Sterile, White | PremierPro | SVS LLC |
25 | 00818566010988 | 8326G | 8326G | PremierPro OR Towel, 17" x 24" Sterile, Green, 6pk | PremierPro | SVS LLC |
26 | 00818566010971 | 8322W | 8322W | OR Towel, 17" x 26" Sterile, White | PremierPro | SVS LLC |
27 | 00818566010964 | X8314W | X8314W | OR Towel, 16" x 26" Xray Detectable Sterile, White | PremierPro | SVS LLC |
28 | 00818566010957 | 8324W | 8324W | PremierPro OR Towel, 17" x 24" Sterile, White, 4pk | PremierPro | SVS LLC |
29 | 00818566010940 | 8324G | 8324G | OR Towel, 17" x 26" Sterile, Green | PremierPro | SVS LLC |
30 | 00818566010759 | 83212B | 83212B | PremierPro OR Towel, 17" x 24" Sterile, Blue, 12pk | PremierPro | SVS LLC |
31 | 00818566010742 | 83210B | 83210B | OR Towel, 17" x 26" Sterile, Blue | PremierPro | SVS LLC |
32 | 00818566010735 | 8321B | 8321B | OR Towel, 17" x 26" Sterile, Blue | PremierPro | SVS LLC |
33 | 00818566010711 | X8314B | X8314B | OR Towel, 16" x 26" Xray Detectable Sterile, Blue | PremierPro | SVS LLC |
34 | 00818566010704 | 8328B | 8328B | PremierPro OR Towel, 17" x 24" Sterile, Blue, 8pk | PremierPro | SVS LLC |
35 | 00818566010698 | X8312W | X8312W | OR Towel, 16" x 26" Xray Detectable Sterile, White | PremierPro | SVS LLC |
36 | 00818566010681 | X8312B | X8312B | OR Towel, 17" x 24" Xray Detectable Sterile, Blue, 2pk | PremierPro | SVS LLC |
37 | 00818566010674 | 8322B | 8322B | OR Towel, 17" x 26" Sterile, Blue | PremierPro | SVS LLC |
38 | 00818566010209 | 8324B | 8324B | OR Towel, 17" x 26" Sterile, Blue | PremierPro | SVS LLC |
39 | 00818566010193 | 8326B | 8326B | OR Towel, 17" x 26" Sterile, Blue | PremierPro | SVS LLC |
40 | 00817415022264 | 783410 | 783410 | 18" x 26" Non Fenestrated Drape Ea | Dealmed | DEALMED MEDICAL SUPPLIES LLC |
41 | 00817415022257 | 783409 | 783409 | 18" x 26" Fenestrated Drape Ea | Dealmed | DEALMED MEDICAL SUPPLIES LLC |
42 | 00815849023345 | CMS-6013 | Film Reinforced XXL Gown - Sterile | Custom Medical Specialties | CUSTOM ASSEMBLIES, INC. | |
43 | 00815384023596 | 4335-20 | 4335-20 | Mini C-arm Drape Kit 46 x 72 | OPTICS ONE | MEDICAL TECHNIQUE, INC. |
44 | 00815384020670 | MRG100 | MRG100 | STARBoard Drape, includes 1 each 12" Tape and 1 each 24" Tape | Medical Resources Group Limited | MEDICAL TECHNIQUE, INC. |
45 | 00814639025675 | A400-MAYO | A400-MAYO | Mayo Stand Cover with SMS reinforcement. Disposable. Sterile. 23x55". | AD Surgical | APPLIED DENTAL, INC. |
46 | 00814639022087 | A400-UTD | Utility Drape Sterile, 22"x25". Absorbent, Impervious PE/PP. | AD Surgical | APPLIED DENTAL, INC. | |
47 | 00814639022063 | A400-HFD | Half Drape Sterile, Absorbent, Impervious PE/PP. 44"x60". | AD Surgical | APPLIED DENTAL, INC. | |
48 | 00814639022056 | A400-APD | Minor Procedure Drape with Adhesive Aperture, Sterile, 22x25" with 2.5" diameter opening. | AD Surgical | APPLIED DENTAL, INC. | |
49 | 00811220033323 | B8310G | B8310G | PremierPro OR Towels, Non-Sterile, Bulk, Green, 100/case | PremierPro | SVS LLC |
50 | 00811220033316 | B8310W | B8310W | PremierPro OR Towels, Non-Sterile, Bulk, White, 100/case | PremierPro | SVS LLC |