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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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Skin Hook - One Prong
GPC MEDICAL LIMITED
REH1062
In Commercial Distribution

  • 08904400200270 ()


  • General external orthopaedic fixation system implantation kit, reusable
ONE SOURCE PACK TK2S21
MEDTRONIC, INC.
TK2S21
Not in Commercial Distribution

  • 00673978524979 ()


  • Autotransfusion system blood component processing set
ONE SOURCE PACK TK2S048
MEDTRONIC, INC.
TK2S048
Not in Commercial Distribution

  • 00673978524962 ()


  • Autotransfusion system blood component processing set
ONE SOURCE PACK TK2S02
MEDTRONIC, INC.
TK2S02
Not in Commercial Distribution

  • 00673978524931 ()


  • Autotransfusion system blood component processing set
TK2S00 ONE SOURCE PACK
MEDTRONIC, INC.
TK2S00
Not in Commercial Distribution

  • 00673978524924 ()


  • Autotransfusion system blood component processing set
ONE SOURCE PACK TK1S21
MEDTRONIC, INC.
TK1S21
Not in Commercial Distribution

  • 00673978524870 ()


  • Autotransfusion system blood component processing set
ONE SOURCE PACK TK1S048
MEDTRONIC, INC.
TK1S048
Not in Commercial Distribution

  • 00673978524863 ()


  • Autotransfusion system blood component processing set
ONE SOURCE PACK TK1S2
MEDTRONIC, INC.
TK1S02
Not in Commercial Distribution

  • 00673978524849 ()


  • Autotransfusion system blood component processing set
ONE SOURCE PACK TK1S00
MEDTRONIC, INC.
TK1S00
Not in Commercial Distribution

  • 00673978524832 ()


  • Autotransfusion system blood component processing set
ORTHOPEDIC ONE FLURO PACK
MEDLINE INDUSTRIES, INC.
DYNJRA1014
In Commercial Distribution

  • 10889942723584 ()
DYNJRA1014

  • General surgical procedure kit, non-medicated, single-use
ONE STEP PREGNANCY TEST
SCI Medic, Inc.
00111
Not in Commercial Distribution

  • 00667742001117 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
All In One Guide
Seaspine Orthopedics Corporation
92-0141
In Commercial Distribution

  • 10889981086893 ()
92-0141

  • Surgical drill guide, reusable
One pouched device, 1F002
Safepath Medical, Inc.
1F002
In Commercial Distribution

  • 00861298002622 ()


  • Silk suture
One pouched device, 1F001
Safepath Medical, Inc.
1F001
Not in Commercial Distribution

  • 00861298002608 ()
1F001

  • Silk suture
ORTHOPEDIC ONE FLURO PACK
MEDLINE INDUSTRIES, INC.
DYNJRA1014C
In Commercial Distribution

  • 10193489783148 ()
  • 40193489783149 ()
DYNJRA1014C

  • General surgical procedure kit, non-medicated, single-use
DRAWER ONE - AIRWAY/BREATHING
MEDLINE INDUSTRIES, INC.
ACC010359
In Commercial Distribution

  • 10889942943340 ()
ACC010359

  • General surgical procedure kit, non-medicated, single-use
One Channel Thermistor, Adult
Ambu A/S
814903-000
In Commercial Distribution

  • 05707480042005 ()

  • Adult
814903-000

  • Polysomnograph
JUMPER CABLES, ONE SET
PMT CORPORATION
2124-10
In Commercial Distribution

  • 00650551100928 ()
2124-10

  • Analytical scalp lead
Drape, one quarter sheet
Elevate Textiles, Inc.
DRAPE0430600-4-SV-0MDGN-000
In Commercial Distribution

  • 00850057346060 ()
3040

  • General surgical procedure kit, non-medicated, reusable
ONE DISPOSABLE STERILE PACK
MEDLINE INDUSTRIES, INC.
DYNDA1512
In Commercial Distribution

  • 10889942162239 ()
DYNDA1512

  • General surgical procedure kit, non-medicated, reusable
ORTHOPEDIC ONE FLURO PACK
MEDLINE INDUSTRIES, INC.
DYNJRA1014B
In Commercial Distribution

  • 10193489582598 ()
  • 40193489582599 ()
DYNJRA1014B

  • General surgical procedure kit, non-medicated, single-use
Positioning Board One Piece
INNOMED, INC.
4095-PB
In Commercial Distribution

  • 00840277107107 ()
4095-PB

  • Leg procedure positioner
NIRANIUM ONE TWO THREE
CMP INDUSTRIES LLC
804003
In Commercial Distribution

  • M4828040030 ()


  • Dental casting non-noble alloy
Sleeve, All in One
PRECISION SPINE, INC.
48-9001
In Commercial Distribution

  • 00840019922517 ()
48-9001

  • Orthopaedic surgical procedure kit, non-medicated, reusable
MODIFIED INSTRUMENT DILATOR ONE
DEPUY SPINE, LLC
698342761
In Commercial Distribution

  • 10705034492803 ()
698342761

  • Laparoscopic access cannula dilator
SYNERGY INSTRUMENT TRAY ONE
Smith & Nephew, Inc.
71366201
In Commercial Distribution

  • 03596010199713 ()
71366201

  • Instrument tray, reusable
Quick Clamp, One Piece
INTEGRA LIFESCIENCES CORPORATION
3595P
In Commercial Distribution

  • M2483595P1 ()
  • 10381780273899 ()
3595P

  • Surgical retraction system, reusable
debritom+ pump, one day
Medaxis AG
2000.0201
Not in Commercial Distribution

  • B724200002011 ()
  • B724200002010 ()


  • Surgical irrigation system nozzle
Tissue Protector One Piece
WRIGHT MEDICAL TECHNOLOGY, INC.
86PS2110
In Commercial Distribution

  • 00889797042307 ()
86PS2110

  • Surgical instrument guard, reusable
FPPL Care One DPS +/-
Ahold U.S.A., Inc.
FPPL
Not in Commercial Distribution

  • 10041520863550 ()
  • 00041520863553 ()
  • 00633472000133 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
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