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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New Wider Grip In-Situ Sagittal Bender, 6.0 MM, Left
ALPHATEC SPINE, INC.
CI-11408-L-60
In Commercial Distribution

  • 00840180521342 ()


  • Manual orthopaedic bender, reusable
New Wider Grip In-Situ Sagittal Bender, 5.5 MM, Left
ALPHATEC SPINE, INC.
CI-11408-L-55
In Commercial Distribution

  • 00840180521335 ()


  • Manual orthopaedic bender, reusable
Abutment New Non Engaging for Angulated Channel JDEvolution Plus
J DENTAL CARE SRL
Abutment New Non Engaging for Angulated Channel JDEvolution Plus
In Commercial Distribution

  • 08056591022145 ()
EVA151C:

  • Dental implant system
new version of Mesa Labs pHoenix XL Dialysate Meter
MESA LABORATORIES, INC.
36-00001
In Commercial Distribution

  • M98536000010 ()
36-00300

  • Multi-parameter device tester
CLOWARD NEW TYPE BLADE RETR, 3'', 23mm NO LIP
SURGIX MEDICAL LLC
G2N52306
In Commercial Distribution

  • G277G2N523060 ()

  • Length: 3 Inch
  • Tip Width 23 mm
G2N52306

  • Hand-held surgical retractor, reusable
CLOWARD NEW TYPE BLADE RETR, 3'', 18mm NO LIP
SURGIX MEDICAL LLC
G2N52304
In Commercial Distribution

  • G277G2N523040 ()

  • Length: 3 Inch
  • Tip Width 18 mm
G2N52304

  • Hand-held surgical retractor, reusable
CLOWARD NEW TYPE BLADE RETR, 3'', 13mm NO LIP
SURGIX MEDICAL LLC
G2N52299
In Commercial Distribution

  • G277G2N522990 ()

  • Length: 3 Inch
  • Tip Width 13 mm
G2N52299

  • Hand-held surgical retractor, reusable
zenith new orleans needle holder, 7-1/8" (18.0 cm)
NOVO SURGICAL, INC.
G92125-29
In Commercial Distribution

  • G586G92125290 ()
G92125-29

  • Suturing needle holder, reusable
CLOWARD NEW TYPE BLADE RETR, 3'', 23mm NO LIP
SURGIX MEDICAL LLC
G2N52306
In Commercial Distribution


  • Length: 3 Inch
  • Tip Width 23 mm
G2N52306

  • Hand-held surgical retractor, reusable
CLOWARD NEW TYPE BLADE RETR, 3'', 18mm NO LIP
SURGIX MEDICAL LLC
G2N52304
In Commercial Distribution


  • Length: 3 Inch
  • Tip Width 18 mm
G2N52304

  • Hand-held surgical retractor, reusable
CLOWARD NEW TYPE BLADE RETR, 3'', 13mm NO LIP
SURGIX MEDICAL LLC
G2N52299
In Commercial Distribution


  • Length: 3 Inch
  • Tip Width 13 mm
G2N52299

  • Hand-held surgical retractor, reusable
Syringe Irrigation Piston Flat Top with New Cath Tip
MCKESSON MEDICAL-SURGICAL INC.
911
In Commercial Distribution

  • 40612479201932 ()
  • 10612479201924 ()


  • ENFit oral/enteral syringe, single-use
Personal Use Kit OC-Auto, for Trinity Health New England
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-THNE
In Commercial Distribution

  • 00816917027128 ()


  • Faecal occult blood IVD, reagent
Personal Use Kit OC-Auto, for Yale New Haven Medical
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-YNHM
In Commercial Distribution

  • 00816917024547 ()


  • Faecal occult blood IVD, reagent
Integra® Miltex® New Orleans Needle Holder 7"
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
8-80
In Commercial Distribution

  • H8348800 ()
  • 10381780441854 ()
8-80

  • Suturing needle holder, reusable
Integra® Jarit® New Orleans Needle Holder, 7"
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
120125
In Commercial Distribution

  • M2741201251 ()
  • 10381780179993 ()
120-125

  • Suturing needle holder, reusable
Image-Line, micro blade, blunt, 14x60mm, gold New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6145H
In Commercial Distribution

  • 00888515190337 ()
73-6145H

  • Surgical retractor/retraction system blade, reusable
Image-Line, micro blade, blunt, 14x55mm, black New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6144H
In Commercial Distribution

  • 00888515190283 ()
73-6144H

  • Surgical retractor/retraction system blade, reusable
Image-Line, micro blade, blunt, 14x50mm, violet New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6143H
In Commercial Distribution

  • 00888515190238 ()
73-6143H

  • Surgical retractor/retraction system blade, reusable
Image-Line, blade, long teeth, 65mm, navy New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6136H
In Commercial Distribution

  • 00888515190047 ()
73-6136H

  • Surgical retractor/retraction system blade, reusable
Image-Line, blade, long teeth, 60mm, gold New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6135H
In Commercial Distribution

  • 00888515190009 ()
73-6135H

  • Surgical retractor/retraction system blade, reusable
Image-Line, blade, long teeth, 55mm, black New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6134H
In Commercial Distribution

  • 00888515189966 ()
73-6134H

  • Surgical retractor/retraction system blade, reusable
Image-Line, blade, long teeth, 50mm, violet New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6133H
In Commercial Distribution

  • 00888515189928 ()
73-6133H

  • Surgical retractor/retraction system blade, reusable
Image-Line, blade, long teeth, 45mm, green New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6132H
In Commercial Distribution

  • 00888515189881 ()
73-6132H

  • Surgical retractor/retraction system blade, reusable
Image-Line, blade, long teeth, 40mm, red New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6131H
In Commercial Distribution

  • 00888515189843 ()
73-6131H

  • Surgical retractor/retraction system blade, reusable
Image-Line, blade, long teeth, 35mm, blue New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6130H
In Commercial Distribution

  • 00888515189805 ()
73-6130H

  • Surgical retractor/retraction system blade, reusable
Image-Line, blade, long teeth, 30mm, silver New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6129H
In Commercial Distribution

  • 00888515189768 ()
73-6129H

  • Surgical retractor/retraction system blade, reusable
Image-Line, blade, short teeth, 65mm, navy New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6127H
In Commercial Distribution

  • 00888515189690 ()
73-6127H

  • Surgical retractor/retraction system blade, reusable
Image-Line, blade, short teeth, 60mm, gold New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6126H
In Commercial Distribution

  • 00888515189645 ()
73-6126H

  • Surgical retractor/retraction system blade, reusable
Image-Line, blade, short teeth, 55mm, black New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6125H
In Commercial Distribution

  • 00888515189607 ()
73-6125H

  • Surgical retractor/retraction system blade, reusable
Image-Line, blade, short teeth, 50mm, violet New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6124H
In Commercial Distribution

  • 00888515189553 ()
73-6124H

  • Surgical retractor/retraction system blade, reusable
Image-Line, blade, short teeth, 45mm, green New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6123H
In Commercial Distribution

  • 00888515189515 ()
73-6123H

  • Surgical retractor/retraction system blade, reusable
Image-Line, blade, short teeth, 40mm, red New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6122H
In Commercial Distribution

  • 00888515189461 ()
73-6122H

  • Surgical retractor/retraction system blade, reusable
Image-Line, blade, short teeth, 35mm, blue New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6121H
In Commercial Distribution

  • 00888515189423 ()
73-6121H

  • Surgical retractor/retraction system blade, reusable
Image-Line, blade, short teeth, 30mm, silver New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6120H
In Commercial Distribution

  • 00888515189379 ()
73-6120H

  • Surgical retractor/retraction system blade, reusable
Image-Line, blade, blunt, 70mm, light green New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6118H
In Commercial Distribution

  • 00888515189256 ()
73-6118H

  • Surgical retractor/retraction system blade, reusable
Schnidt Tonsil Forceps, 7 1/2", new old pattern
Avalign Technologies, Inc.
1-743075D
In Commercial Distribution

  • 00190776388652 ()


  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
New issued for UMiami RTOK_0MRTK01_ATC_Lift sheet_Armboard cover_ Bags_strap_mophead_Non-sterile_12ea/cs
GRI Medical & Electronic Technology Co., Ltd.
49-OMRTK01
In Commercial Distribution

  • 26931918177981 ()
  • 16931918177984 ()


  • Operating room turnover kit
NAVIOS EX ACQUISITION NEW USER SOFTWARE V2.0 WIN 7
BECKMAN COULTER IRELAND INC.
ACQUISITION NEW USER SOFTWARE V2.0 WIN 7
In Commercial Distribution

  • 15099590683245 ()
B91237

  • Laboratory instrument/analyser application software IVD
Hinge Cap with Pins (New Style) for Standby Model
W. A. BAUM CO., INC.
2233NS
In Commercial Distribution

  • 00810010924780 ()
2233NS

  • Aneroid manual sphygmomanometer
Thiol Broth 4 mL Solution in 12x80 NEW Tube
COPAN ITALIA SPA
4U002N
In Commercial Distribution

  • 28053326000328 ()
  • 18053326000321 ()
  • 08053326000324 ()
4U002N

  • General specimen container IVD, additive/medium
CABLE 367675 ISTM TST W/GP 6PK NEW CABLE
MEDTRONIC, INC.
367675
In Commercial Distribution

  • 20643169439430 ()
  • 00643169439436 ()

  • Length: 75.0 Centimeter


  • Electrical-only medical device connection cable, reusable
CABLE 367637 ISTM TST W/GP 6PK NEW CABLE
MEDTRONIC, INC.
367637
Not in Commercial Distribution

  • 20643169439423 ()
  • 00643169439429 ()

  • Length: 37.0 Centimeter


  • Electrical-only medical device connection cable, reusable
CABLE 357975 ISTM TEST NO GP 6PK NEW CBL
MEDTRONIC, INC.
357975
In Commercial Distribution

  • 20643169439416 ()
  • 00643169439412 ()

  • Length: 75.0 Centimeter


  • Electrical-only medical device connection cable, reusable
CABLE 357937 ISTM TEST NO GP 6PK NEW CBL
MEDTRONIC, INC.
357937
In Commercial Distribution

  • 20643169439409 ()
  • 00643169439405 ()

  • Length: 37.0 Centimeter


  • Electrical-only medical device connection cable, reusable
LinkStation MINI with Australia and New Zealand power cord
ORTHOSENSOR INC
LinkStation MINI
Not in Commercial Distribution

  • 00816818020457 ()
05000-002

  • Arthroplasty force sensor display unit
GC RELINE™ II Disposable Brush (6)
Gc America Inc.
010282
In Commercial Distribution

  • 14548161321457 ()
010282

  • Denture reliner, soft, professional
GC RELINE™ II Wheel for Finishing (12)
Gc America Inc.
010279
In Commercial Distribution

  • 14548161321440 ()
010279

  • Denture reliner, soft, professional
GC RELINE ™ II Point for Trimming (3)
Gc America Inc.
010276
In Commercial Distribution

  • 14548161321433 ()
010276

  • Denture reliner, soft, professional
GC RELINE™ II Remover (for Resin): 1 x 5g (5.5mL)
Gc America Inc.
010274
In Commercial Distribution

  • 14548161321426 ()
010274

  • Denture reliner, soft, professional
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