Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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GEISINGER WYOMING VALLEY MANI
MEDLINE INDUSTRIES, INC.
VASC1331
In Commercial Distribution

  • 40195327141999 ()
  • 10195327141998 ()
VASC1331

  • General surgical procedure kit, non-medicated, single-use
10M - Wyoming Body Fluid
Certified Safety Manufacturing, Inc.
FK204-903
In Commercial Distribution

  • 00766588049038 ()
FK204-903

  • First aid kit, medicated
Wyoming BFK+ - 10 Refill
Certified Safety Manufacturing, Inc.
FKR204-903
In Commercial Distribution

  • 00766588047034 ()
FKR204-903

  • First aid kit, medicated
MTO PROTECTION STATION KIT WYOMING
MEDLINE INDUSTRIES, INC.
65130563
In Commercial Distribution

  • 10193489061628 ()
65130563

  • Angiography kit
MTO LEFT HEART KIT-GEISINGER WYOMING, PG
MEDLINE INDUSTRIES, INC.
65070931
In Commercial Distribution

  • 10193489060843 ()
65070931

  • Angiography kit
MTO LEFT HEART KIT GEISINGER WYOMING
MEDLINE INDUSTRIES, INC.
60070931
In Commercial Distribution

  • 20193489044246 ()
  • 10193489044249 ()
60070931

  • Angiography kit
36PW Genesee & Wyoming Fleet - Poly White
Certified Safety Manufacturing, Inc.
K614-022
In Commercial Distribution

  • 00766588149226 ()
K614-022

  • Cardiopulmonary resuscitation mask, single-use
  • Dressing-fixation skin adhesive tape, non-silicone
  • Non-woven gauze pad
  • Endothermic cold therapy pack
  • First aid kit, medicated
  • Non-woven gauze roll/sheet
  • Wound-nonadherent dressing, absorbent, non-antimicrobial
  • Non-rebreathing valve, single-use
16PW - Genesee & Wyoming RR - Poly White
Certified Safety Manufacturing, Inc.
K612-087
In Commercial Distribution

  • 00766588120874 ()
K612-087

  • Non-woven gauze pad
  • First aid kit, medicated
  • Dressing-fixation skin adhesive tape, non-silicone
  • Wound-nonadherent dressing, absorbent, non-antimicrobial
  • Cardiopulmonary resuscitation mask, single-use
  • Adhesive bandage
  • Non-rebreathing valve, single-use
  • Non-woven gauze roll/sheet
Dynesys® TL Hex Driver
ZIMMER SPINE, INC.
07.00737.701
In Commercial Distribution

  • 00880304989368 ()
07.00737.701

  • Orthopaedic surgical procedure kit, non-medicated, reusable
No Description
Laboratoires Bodycad Inc
027-207-100
In Commercial Distribution

  • 00688346002065 ()
027-207-100

  • Surgical screwdriver, reusable
No Description
Laboratoires Bodycad Inc
027-201-100
In Commercial Distribution

  • 00688346001044 ()
027-201-100

  • Surgical screwdriver, reusable
The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Relja Innovations LLC
RI-2427-C
In Commercial Distribution

  • 00860005968800 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
EasyShift Repositioning System V3 for 42" wide mattress, compatible with EasyShift Zipper Sheet
Seneca Devices, Inc.
EAS-42-Z
In Commercial Distribution

  • 00860004936817 ()


  • Bed mattress support platform, hydraulic
  • Intensive-care patient transport system, ventilatory support, neonatal
No Description
BUY SUPPLY INC
PG-IRT1602
In Commercial Distribution

  • 00860004330691 ()


  • Infrared patient thermometer, ear
No Description
FlexDex Surgical
8ND1L
In Commercial Distribution

  • 00860004002147 ()


  • Suturing needle holder, reusable
No Description
FlexDex Surgical
8ND1M
In Commercial Distribution

  • 00860004002130 ()


  • Suturing needle holder, reusable
No Description
FlexDex Surgical
FD-335 ND
Not in Commercial Distribution

  • 00860004002116 ()
  • 00860004002109 ()


  • Suturing needle holder, single-use
Pump Driver Service Replacement Kit
Breethe, Inc.
001-0301-003
In Commercial Distribution

  • 00860001797947 ()
001-0301-003

  • Cardiopulmonary bypass system, non-roller type
Screwdriver hexagon
Oticon Medical AB
M50534
In Commercial Distribution

  • 05712149001026 ()
M50534

  • Surgical screwdriver, reusable
Handle with screwdriver. Consists of handle (DM DI 05712149024568) and screwdriver machine bit (DM DI 05712149000562).
Oticon Medical AB
M50437
In Commercial Distribution

  • 05712149000654 ()
  • 05712149024568 ()
M50437

  • Surgical screwdriver, reusable
Square fit connection, machine
Oticon Medical AB
M50386
In Commercial Distribution

  • 05712149000586 ()
M50386

  • Surgical screwdriver, reusable
Screwdriver, machine, 35mm
Oticon Medical AB
M50384
In Commercial Distribution

  • 05712149000562 ()
M50384

  • Surgical screwdriver, reusable
Nylon Facing For #1 Mallet
HU-FRIEDY MFG. CO., LLC
PTNFM1
Not in Commercial Distribution

  • 10889950020668 ()
PTNFM1

  • Surgical mallet
Insertion indicator
Oticon Medical AB
M52366
Not in Commercial Distribution

  • 05712149009909 ()
M52366

  • Surgical screwdriver, reusable
Abutment inserter, machine
Oticon Medical AB
M51695
In Commercial Distribution

  • 05712149005895 ()
M51695

  • Surgical screwdriver, reusable
Le Fort Surgical Guide - Wall with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543494 ()
GCLPFBC

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Slots with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543487 ()
GCLRFBC

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Wall Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543470 ()
GCLPBC

  • Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Slots Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543463 ()
GCLRBC

  • Custom-made orthopaedic/craniofacial surgical guide
Final Orthognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543456 ()
FFCOBC

  • Custom-made orthopaedic/craniofacial surgical guide
Intermediate Orhognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860007543449 ()
FICOBC

  • Custom-made orthopaedic/craniofacial surgical guide
2.0 - 3.2 Pin Driver Assembly
Insurgical, Inc.
320-0070-001
In Commercial Distribution

  • 00860007230066 ()
9250022

  • Pin-driving power tool attachment
3.2 - 4.0 Pin Driver Assembly
Insurgical, Inc.
320-0107-001
In Commercial Distribution

  • 00860007230059 ()
9250023

  • Pin-driving power tool attachment
SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.
OPUS KSD, INC.
SU-10
In Commercial Distribution

  • 10867469000234 ()
  • 00867469000237 ()
412010

  • Skin stapler/staple, bioabsorbable
SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.
OPUS KSD, INC.
SU-10
In Commercial Distribution

  • 10867469000227 ()
  • 00867469000220 ()
412010

  • Skin stapler/staple, bioabsorbable
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES, SINGLE JAW
Medcad
MC-KTP010-H
In Commercial Distribution

  • 00864582000298 ()
MC-KTP010-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES, SINGLE JAW
Medcad
MC-KTP010
In Commercial Distribution

  • 00864582000281 ()
MC-KTP010

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES
Medcad
MC-KTP000-H
In Commercial Distribution

  • 00864582000274 ()
MC-KTP000-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
OsteoMed Manual Driver Handle
FHC, INC.
66-WP-DH-00323
In Commercial Distribution

  • 00873263003237 ()
66-WP-DH

  • Neurological stereotactic surgery system
WayPoint Combination Driver Bit with Collar
FHC, INC.
66-WP-CD-01-00320
In Commercial Distribution

  • 00873263003206 ()
66-WP-CD-01

  • Neurological stereotactic surgery system
WayPoint Combination Driver Bit
FHC, INC.
66-WP-CD-00318
In Commercial Distribution

  • 00873263003183 ()
66-WP-CD

  • Neurological stereotactic surgery system
WayPoint Surgical Kit Contains: Anchor Hex Wrench - 66-WP-HW Burr Hole Entry Marker Tool & Bushing 66-MP-EM STar SteriSuite Case 6mm Standoff Wrench - 66-WP-SW WayPoint Driver Handle - 66-WP-DH Combination Driver Bit - 66-WP-CD microTargeting Sterilization Tray - 67-00-1
FHC, INC.
66-WP-MR-00317
Not in Commercial Distribution

  • 00873263001721 ()
  • 00873263003176 ()
66-WP-MR

  • Neurological stereotactic surgery system
No Description
PRO-DEX, INC.
APD-SC-001
In Commercial Distribution

  • 00860540000294 ()


  • Device sterilization/disinfection container, reusable
No Description
PRO-DEX, INC.
05.000.020LN
In Commercial Distribution

  • 00860540000225 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
68020522
In Commercial Distribution

  • 05712821014665 ()
68020522

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
68020521
In Commercial Distribution

  • 05712821014658 ()
68020521

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
68020520
In Commercial Distribution

  • 05712821014641 ()
68020520

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
68020519
In Commercial Distribution

  • 05712821014634 ()
68020519

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
68020518
In Commercial Distribution

  • 05712821014627 ()
68020518

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is used as an accessory for dental scanners in order to locate the exact position of the implants placed in the patient’s jawbone. The Scan Body is intended to be attached to the implant/abutment directly in the patients’ mouth when using an intra-oral scanner. It is manufactured from biocompatible titanium alloy (TiAl6V4 ELI). The Scan Body Driver that is provided separately, is used to fasten the Scan Body to the Implant.
Elos Medtech Pinol A/S
68020517
In Commercial Distribution

  • 05712821014610 ()
68020517

  • Dental implant suprastructure, temporary, preformed, reusable
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