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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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PlasmaJet Neutral Plasma Surgery System - M397PS102130NZ0

PlasmaJet V3 Plus Console System (New Zealand)
PLASMA SURGICAL, INC
PS10-2130-NZ
In Commercial Distribution

  • M397PS102130NZ0 ()
PS10-2130-NZ

  • Plasma surgical system

Top Quality Manufacturing - TQ26FM2180611

TQMPL Face Mask - ASTM 1 - White - New
TOP QUALITY MANUFACTURING, INC.
FM2-1806
In Commercial Distribution

  • TQ26FM2180610 ()
  • TQ26FM2180611 ()


  • Surgical/medical face mask, non-antimicrobial, single-use

Top Quality Manufacturing - TQ26FM2180511

TQMPL Face Mask - ASTM 1 - Yellow - New
TOP QUALITY MANUFACTURING, INC.
FM2-1805
In Commercial Distribution

  • TQ26FM2180510 ()
  • TQ26FM2180511 ()


  • Surgical/medical face mask, non-antimicrobial, single-use

Top Quality Manufacturing - TQ26FM2180211

TQMPL Face Mask - ASTM 1 - Pink - New
TOP QUALITY MANUFACTURING, INC.
FM2-1802
In Commercial Distribution

  • TQ26FM2180210 ()
  • TQ26FM2180211 ()


  • Surgical/medical face mask, non-antimicrobial, single-use

Top Quality Manufacturing - TQ26FM2180111

TQMPL Face Mask - ASTM 1 - Blue - New
TOP QUALITY MANUFACTURING, INC.
FM2-1801
In Commercial Distribution

  • TQ26FM2180110 ()
  • TQ26FM2180111 ()


  • Surgical/medical face mask, non-antimicrobial, single-use

NA - 10888551041478

SAW BLADE GENESIS II SMALL NEW STRYKER
STERILMED, INC.
SMI71440389
Not in Commercial Distribution

  • 10888551041478 ()
71440389

  • Surgical saw blade, reciprocating, single-use

DRESSING CHANGE TRAY - M752MSDCC183000

CONVENIENCE KIT FOR NEW OR REPLACEMENT DRESSING
STRADIS MEDICAL LLC
MSDC-C18300
In Commercial Distribution

  • M752MSDCC183000 ()
  • M752MSDCC183005 ()


  • Wound dressing kit, medicated

N/A - 00885074421490

CASE 9568013 MAST QUADRANT OUTR TRAY NEW
MEDTRONIC SOFAMOR DANEK, INC.
9568013
In Commercial Distribution

  • 00885074421490 ()


  • Instrument tray, reusable

N/A - 00885074421469

CASE 8390310 MAST QUAD LGCY OUTR NEW
MEDTRONIC SOFAMOR DANEK, INC.
8390310
In Commercial Distribution

  • 00885074421469 ()


  • Instrument tray, reusable

Sofreliner Tough - 04548190234110

S Paste
TOKUYAMA DENTAL CORPORATION
23411
In Commercial Distribution

  • 04548190234110 ()


  • Denture reliner, elastic, long-term
  • Denture reliner, elastic, short-term

Sofreliner Tough - 04548190234011

S Kit
TOKUYAMA DENTAL CORPORATION
23401
In Commercial Distribution

  • 04548190234011 ()


  • Denture reliner, elastic, short-term
  • Denture reliner, elastic, long-term

Ducks Unlimited - 00781096116706

Spectacle Frame, Size 51-19-140
MCGEE GROUP, INC., THE
DU Brunswick Gunmetal/Black
In Commercial Distribution

  • 00781096116706 ()
DUBRUN0GNBK051S19

  • Spectacle frame

Air Ranger Pro - 00841965103326

Assy,Mattress/Pkg,SIV 3K Plus,
Tridien Medical
New Source
In Commercial Distribution

  • 00841965103326 ()
53-SM52S3-48NSM

  • Alternating-pressure bed mattress overlay system

Air Ranger Pro - 00841965103319

Assy,Ctlr/Pkg,SIV 3K Plus,NSM
Tridien Medical
New Source
In Commercial Distribution

  • 00841965103319 ()
23SM3000-ARPP

  • Alternating-pressure bed mattress overlay system

Air Ranger Pro - 00841965103333

Assy,MatPkg,54",S3K,NSM
Tridien Medical
New Source
In Commercial Distribution

  • 00841965103333 ()
53-SM52S3-54NSM

  • Alternating-pressure bed mattress overlay system

babaka - 06950715503294

Back Brace
Cofoe Medical Technology Co.,Ltd
New E+
In Commercial Distribution

  • 06950715503294 ()


  • Lumbar spine orthosis

babaka - 06950715503287

Back Brace
Cofoe Medical Technology Co.,Ltd
New L
In Commercial Distribution

  • 06950715503287 ()


  • Lumbar spine orthosis

Cofoe - 06950715501597

It is intended for use in correcting improper posture, such as hunching or slouching, and improving overall body alignment. It is suitable for both adults and children who need assistance in maintaining proper posture.
Cofoe Medical Technology Co.,Ltd
New E+
In Commercial Distribution

  • 06950715501597 ()


  • Lumbar spine orthosis

Cofoe - 06950715501566

It is intended for use in correcting improper posture, such as hunching or slouching, and improving overall body alignment. It is suitable for both adults and children who need assistance in maintaining proper posture.
Cofoe Medical Technology Co.,Ltd
New L
In Commercial Distribution

  • 06950715501566 ()


  • Lumbar spine orthosis

CARDINAL HEALTH - 10887488521701

KIT,G 3 ANT CERV LAMI,NEW YOR
Cardinal Health 200, LLC
PNV2CL34J
In Commercial Distribution

  • 50887488521709 ()
  • 10887488521701 ()
PNV2CL34J

  • Neurosurgical procedure kit, non-medicated, single-use

NEW TRANSPARENT SILICONE MASK SIZE#5.ADULT LARGE - 04716770865539

NEW TRANSPARENT SILICONE MASK SIZE#5.ADULT LARGE
BESMED HEALTH BUSINESS CORP.
SM-86553
In Commercial Distribution

  • 04716770865539 ()


  • Cardiopulmonary resuscitation mask, reusable

NEW TRANSPARENT SILICONE MASK SIZE#3.CHILD LARGE - 04716770865331

NEW TRANSPARENT SILICONE MASK SIZE#3.CHILD LARGE
BESMED HEALTH BUSINESS CORP.
SM-86533
In Commercial Distribution

  • 04716770865331 ()


  • Cardiopulmonary resuscitation mask, reusable

Ellex - 09342395001318

WINDOWS 7 UPGRADE KIT, NEW GENERATION EYE CUBED
ELLEX MEDICAL PTY LTD
6448970
In Commercial Distribution

  • 09342395001318 ()


  • Ophthalmic ultrasound imaging system

NA - 00613994353641

ACCY 3550-29 NEW PLUG CLOSED BOOT US MKT
MEDTRONIC, INC.
3550-29
Not in Commercial Distribution

  • 00613994353641 ()


  • Neurosurgical procedure kit, non-medicated, single-use

NA - 00613994660299

PROG 37752 RECHARGE ULTRA NEW LIT US MKT
MEDTRONIC, INC.
37752
Not in Commercial Distribution

  • 00613994660299 ()


  • Noninvasive device battery charger

NA - 00643169449169

EXT 3708695 DBS NEW BOOT US SYM MRI
MEDTRONIC, INC.
3708695
In Commercial Distribution

  • 00643169449169 ()

  • Length: 95.0 Centimeter


  • Deep brain electrical stimulation system

NA - 00643169449152

EXT 3708660 DBS NEW BOOT US SYM MRI
MEDTRONIC, INC.
3708660
In Commercial Distribution

  • 00643169449152 ()

  • Length: 60.0 Centimeter


  • Deep brain electrical stimulation system

NA - 00643169449145

EXT 3708640 DBS NEW BOOT US SYM MRI
MEDTRONIC, INC.
3708640
Not in Commercial Distribution

  • 00643169449145 ()

  • Length: 40.0 Centimeter


  • Deep brain electrical stimulation system

NAMIC - 10193489072808

MTS CLOS SYS W/CIL-YALE NEW HAVEN PG
MEDLINE INDUSTRIES, INC.
602500213
In Commercial Distribution

  • 20193489072805 ()
  • 10193489072808 ()
602500213

  • Angiography kit

NAMIC - 10193489072792

MTS PTCA KIT W/ SYRINGE YALE NEW HAVEN
MEDLINE INDUSTRIES, INC.
602500212
In Commercial Distribution

  • 20193489072799 ()
  • 10193489072792 ()
602500212

  • Angiography kit

NAMIC - 10193489071344

MTS NEURO KIT 2 NEW ENGLAND MED CTR
MEDLINE INDUSTRIES, INC.
601400111
In Commercial Distribution

  • 20193489071341 ()
  • 10193489071344 ()
601400111

  • Angiography kit

NAMIC - 10193489062304

MTO LEFT HEART KIT NEW HANOVER REG MED
MEDLINE INDUSTRIES, INC.
65141392
In Commercial Distribution

  • 10193489062304 ()
65141392

  • Angiography kit

NAMIC - 10193489049718

MTO ANGIO KIT HENRY MAYO NEW HALL MEM
MEDLINE INDUSTRIES, INC.
60182193
In Commercial Distribution

  • 20193489049715 ()
  • 10193489049718 ()
60182193

  • Angiography kit

AMC - 00849593012904

3 Lead New NK 12 Pin Patient Cable
Advantage Medical Electronics, LLC
CB-723600
In Commercial Distribution

  • 00849593012904 ()


  • Electrical-only medical device connection cable, reusable

Gimmi - 04049047779506

NEW S SUTURE SCISSORS ANGULAR LENGTH 140 MM
Gimmi GmbH
WA.1333.14
In Commercial Distribution

  • 04049047779506 ()
WA.1333.14

  • Nail scissors, reusable

AMC - 00849593040532

New Small Ear Clip Nellcor comp., SpO2 Sensor
Advantage Medical Electronics, LLC
PR-A220-1011N
In Commercial Distribution

  • 00849593040532 ()


  • Telemetric pulse oximeter

Power Dental U.S.A., Inc. - D943N6934N00

BLACK EDITION FOR MICRO SURGICAL BLADE HD new
Power Dental U.S.A. Inc.
N6934N
Not in Commercial Distribution

  • D943N6934N00 ()
N6934N

  • Scalpel handle, reusable

Power Dental U.S.A., Inc. - D943N5303CB00

HEMOSTATIC FORCEPS HALSTED-MOSQUITO 12.5cm CVD ALL BLACK NEW
Power Dental U.S.A. Inc.
N5303CB
Not in Commercial Distribution

  • D943N5303CB00 ()
N5303CB

  • Dressing/utility forceps, scissors-like, reusable

Power Dental U.S.A., Inc. - D943N4613RAN00

CALIPER CLC 40 CWM, 17cm CONTACT FRONT NEW
Power Dental U.S.A. Inc.
N4613RAN
In Commercial Distribution

  • D943N4613RAN00 ()
N4613RAN

  • General-purpose calliper, metallic

Power Dental U.S.A., Inc. - D943N3895GN00

POWER TWIST PERIOTOME 4mm ANTERIOR, STR-R TITANIUM NEW
Power Dental U.S.A. Inc.
N3895GN
In Commercial Distribution

  • D943N3895GN00 ()
N3895GN

  • Periotome, reusable

Power Dental U.S.A., Inc. - D943N3894GN00

POWER TWIST PERIOTOME 4mm ANTERIOR, STR-L TITANIUM NEW
Power Dental U.S.A. Inc.
N3894GN
In Commercial Distribution

  • D943N3894GN00 ()
N3894GN

  • Periotome, reusable

MEDTRONIC® DBS™ - 00643169141766

LIT 3339L DYSTONIA 37603 W/3389S NEW EXT
MEDTRONIC, INC.
3339
In Commercial Distribution

  • 00643169141766 ()


  • Deep brain electrical stimulation system

MEDTRONIC® DBS™ - 00643169141759

LIT 3337L DYSTONIA 37603 W/3387S NEW EXT
MEDTRONIC, INC.
3337
In Commercial Distribution

  • 00643169141759 ()


  • Deep brain electrical stimulation system

MEDTRONIC® DBS™ - 00643169141742

LIT 3319L DYSTONIA 37601 W/3389S NEW EXT
MEDTRONIC, INC.
3319
In Commercial Distribution

  • 00643169141742 ()


  • Deep brain electrical stimulation system

MEDTRONIC® DBS™ - 00643169141735

LIT 3317L DYSTONIA 37601 W/3387S NEW EXT
MEDTRONIC, INC.
3317
In Commercial Distribution

  • 00643169141735 ()


  • Deep brain electrical stimulation system

Vitalitec Clip Appliers - 00850001784184

PJ120-E (20cm Applier for New 9 Small Clip)
VITALITEC INTERNATIONAL, INC.
PJ120-E
In Commercial Distribution

  • 00850001784184 ()

  • Length: 20 Centimeter


  • Open-surgery ligation clip applier

CARDINAL HEALTH - 10887488198187

KIT,G 3 ANT CERV LAMI,NEW YOR
Cardinal Health 200, LLC
PNV2CL34H
In Commercial Distribution

  • 50887488198185 ()
  • 10887488198187 ()
PNV2CL34H

  • Neurosurgical procedure kit, non-medicated, single-use

RZ Medizintechnik GmbH - 04049197083485

NEW ORLEANS TC Needle holder,straight 18cm, 7"
RZ-Medizintechnik GmbH
180-553-180
In Commercial Distribution

  • 04049197083485 ()
180-553-180

  • Suturing needle holder, reusable

Sil-Flex - 04710810083198

New Sil-Flex Silicone Mask size 3, Child Large
GaleMed Xiamen Co., Ltd.
5181
In Commercial Distribution

  • 04710810083198 ()
  • 24710810083192 ()
  • 44710810083196 ()


  • Anaesthesia face mask, reusable

ACE - 00614950014255

ADAPTER UNIVERSAL FEMALE 15MM NEW STYLE L/F
ACE SURGICAL SUPPLY CO., INC.
0032276
In Commercial Distribution

  • 00614950014255 ()

  • Length: 15 Millimeter
0032276

  • Luer/non-ISO80369-standardized linear connector, reusable
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