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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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Alignment Rod with Coupler
B-ONE ORTHO, CORP.
8829001001
In Commercial Distribution

  • 00843575104526 ()
8829001001

  • Orthopaedic implant/instrument assembling device
RAMUS CLAMP, WITH CHAIN
Stryker Leibinger GmbH & Co. KG
01-01450
In Commercial Distribution

  • 04546540134011 ()

  • Length: 18.5 Centimeter
01-01450

  • External orthopaedic fixation system, reusable
Screw Rack with Lid
Stryker GmbH
901588
In Commercial Distribution

  • 04546540132093 ()
901588

  • Surgical instrument/implant rack
Screw Rack with Lid
Stryker GmbH
901578
In Commercial Distribution

  • 04546540132017 ()
901578

  • Surgical instrument/implant rack
Screw Rack with Lid
Stryker GmbH
901560
In Commercial Distribution

  • 04546540131935 ()
901560

  • Surgical instrument/implant rack
Guide Wire with Calibrations
Stryker GmbH
702627
In Commercial Distribution

  • 04546540112903 ()
702627

  • Orthopaedic intraoperative positioning pin, single-use
Preci-Clix Post with Ball
Alphadent NV
1293 C
In Commercial Distribution

  • 04260576940551 ()

  • post length
  • Length: 7 Millimeter
1293 C

  • Root canal post, preformed
Preci-Clix Post with threads
Alphadent NV
1291 C
In Commercial Distribution

  • 04260576940537 ()

  • post length
  • Length: 7 Millimeter
1291 C

  • Root canal post, preformed
with Control-IQ 7.X
Tandem Diabetes Care, Inc.
1014081
In Commercial Distribution

  • 00389152408170 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
with Control-IQ 7.X
Tandem Diabetes Care, Inc.
1013117
In Commercial Distribution

  • 00389152311777 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
Pressure syringe with handle
PULPDENT CORPORATION
PS-O
In Commercial Distribution

  • D701PSO2 ()


  • Endodontic filling material condenser
KIT, RECOVERY WITH PILLOW
Cardinal Health 200, LLC
OMS4401323
In Commercial Distribution

  • 50888439006504 ()
  • 10888439006506 ()
OMS4401323

  • General surgical procedure kit, non-medicated, single-use
U-Joint Awl With Sleeve
Altus Spine, LLC
1030-0100A
In Commercial Distribution

  • 00843210180281 ()


  • Bone awl, reusable
U-Joint Awl With Sleeve
Altus Spine, LLC
1030-0100A
In Commercial Distribution

  • 00843210147024 ()


  • Bone awl, reusable
Senti device with touchscreen
PATH medical GmbH
100097
Not in Commercial Distribution

  • 04260223142529 ()


  • Tone audiometer
MaxDisc Tray with lid
Hoogland Spine Products GmbH
1001-IS 011
In Commercial Distribution

  • 04260200312631 ()


  • Instrument tray, reusable
BONE PLATE, WITH BAR
Stryker Leibinger GmbH & Co. KG
54-05106
In Commercial Distribution

  • 04546540237989 ()

  • Bar Length: 4.4 Millimeter
  • Number of Screw Holes: 4.0 Holes
54-05106

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ESO With Extended Tip
Given Imaging, Inc.
RFG-8000-15
In Commercial Distribution

  • 04260167482491 ()


  • Manometric gastrointestinal motility analysis system
ESO With Extended Tip
Given Imaging, Inc.
800015
In Commercial Distribution

  • 04260167482439 ()


  • Manometric gastrointestinal motility analysis system
Curette with Fibre Handle
GPC MEDICAL LIMITED
COG803
In Commercial Distribution

  • 08904400200027 ()


  • General external orthopaedic fixation system implantation kit, reusable
VIAL SYRINGE WITH ASPIRATOR
BMT Medizintechnik GmbH
STF-1
In Commercial Distribution

  • 04251725217815 ()
STF-1

  • Dental anaesthesia syringe, reusable
Bending Forceps, With Cutter
I.T.S. GmbH
KH.267.16
In Commercial Distribution

  • 09120069811285 ()
KH.267.16

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Forceps, With Gauge Function
I.T.S. GmbH
62830
In Commercial Distribution

  • 09120069810967 ()
62830

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Audiometric receiver with headband
BHM-Tech Produktionsgesellschaft m.b.H.
BC-1-BONE-W-HEADBAND/GR7024
In Commercial Distribution

  • 09120041051661 ()
77735155

  • Auditory cranial bone vibrator
Audiometric receiver with headband
BHM-Tech Produktionsgesellschaft m.b.H.
BC-1-BONE-W-HEADBAND
In Commercial Distribution

  • 09120041051500 ()
77735020

  • Auditory cranial bone vibrator
Inserter Shaft with Stop
Pioneer Surgical Technology, Inc.
30-CC-INSRTSHAFT-S
Not in Commercial Distribution

  • 00846468062712 ()


  • General internal orthopaedic fixation system implantation kit
KNEE WITH ACL RECONSTRUCTION
Cardinal Health 200, LLC
SOP34ARKS1
In Commercial Distribution

  • 50888439523971 ()
  • 10888439523973 ()
SOP34ARKS1

  • Orthopaedic surgical procedure kit, non-medicated, single-use
CATARACT WITH TUBING PACK
Cardinal Health 200, LLC
SEY44CAASC
In Commercial Distribution

  • 50888439529836 ()
  • 10888439529838 ()
SEY44CAASC

  • Ophthalmic surgical procedure kit, medicated, single-use
Reduction Instrument, With Scale
Stryker GmbH
07-40101
In Commercial Distribution

  • 04546540156198 ()

  • Length: 7.0 Centimeter
07-40101

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Home Use with camera
MASIMO CORPORATION
9784
In Commercial Distribution

  • 00843997014199 ()
  • 00843997013673 ()


  • Pulse Co-oximeter
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