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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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Back-N-Black with Dual Panels - 00802357632541

No Description
MEDICAL SPECIALTIES INCORPORATED
163254
In Commercial Distribution

  • 00802357632541 ()


  • Lumbar spine orthosis

Back-N-Black with Dual Panels - 00802357632527

No Description
MEDICAL SPECIALTIES INCORPORATED
163252
In Commercial Distribution

  • 00802357632527 ()


  • Lumbar spine orthosis

Back-n-Black with Thermo Pocket - 00802357632275

No Description
MEDICAL SPECIALTIES INCORPORATED
163227
In Commercial Distribution

  • 00802357632275 ()


  • Lumbar spine orthosis

Back-n-Black with Thermo Pocket - 00802357632268

No Description
MEDICAL SPECIALTIES INCORPORATED
163226
In Commercial Distribution

  • 00802357632268 ()


  • Lumbar spine orthosis

Back-n-Black with Thermo Pocket - 00802357632251

No Description
MEDICAL SPECIALTIES INCORPORATED
163225
In Commercial Distribution

  • 00802357632251 ()


  • Lumbar spine orthosis

Back-n-Black with Thermo Pocket - 00802357632244

No Description
MEDICAL SPECIALTIES INCORPORATED
163224
In Commercial Distribution

  • 00802357632244 ()


  • Lumbar spine orthosis

Back-n-Black with Thermo Pocket - 00802357632220

No Description
MEDICAL SPECIALTIES INCORPORATED
163222
In Commercial Distribution

  • 00802357632220 ()


  • Lumbar spine orthosis

Back-n-Black with Thermo Pocket - 00802357632213

No Description
MEDICAL SPECIALTIES INCORPORATED
263221
In Commercial Distribution

  • 00802357632213 ()


  • Lumbar spine orthosis

Straight abutment with shoulder - 07290018434543

No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
4mm
In Commercial Distribution

  • 07290018434543 ()
SA4

  • Dental implant system

Straight abutment with shoulder - 07290018434536

No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
3mm
In Commercial Distribution

  • 07290018434536 ()
SA3

  • Dental implant system

Straight abutment with shoulder - 07290018434529

No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
2mm
In Commercial Distribution

  • 07290018434529 ()
SA2

  • Dental implant system

Straight abutment with shoulder - 07290018434512

No Description
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
1mm
In Commercial Distribution

  • 07290018434512 ()
SA1

  • Dental implant system

Vessel Dilator with Collar - 00886333210558

Vessel Dilator with Collar 9 French
ARGON MEDICAL DEVICES, INC.
392414
Not in Commercial Distribution

  • 10886333210555 ()
  • 00886333210558 ()

  • 9 French
392414

  • Fascial tissue dilator, single-use

Vessel Dilator with Collar - 00886333210541

Vessel Dilator with Collar 8F
ARGON MEDICAL DEVICES, INC.
392413
Not in Commercial Distribution

  • 10886333210548 ()
  • 00886333210541 ()

  • 8 French
392413

  • Fascial tissue dilator, single-use

Vessel Dilator with Collar - 00886333210534

Vessel Dilator with Collar 7 French
ARGON MEDICAL DEVICES, INC.
392412
Not in Commercial Distribution

  • 10886333210531 ()
  • 00886333210534 ()

  • 7 French
392412

  • Fascial tissue dilator, single-use

Vessel Dilator with Collar - 00886333210527

Vessel Dilator with Collar 6 French
ARGON MEDICAL DEVICES, INC.
392411
Not in Commercial Distribution

  • 10886333210524 ()
  • 00886333210527 ()

  • 6 French
392411

  • Fascial tissue dilator, single-use

Vessel Dilator with Collar - 00886333210510

Vessel Dilator with Collar 5 French
ARGON MEDICAL DEVICES, INC.
392410
Not in Commercial Distribution

  • 10886333210517 ()
  • 00886333210510 ()

  • 5 French
392410

  • Fascial tissue dilator, single-use

AEROBIKA OPEP with Manometer - 00762860105041

AEROBIKA OPEP with Manometer
Trudell Medical International
110504
In Commercial Distribution

  • 10762860105048 ()
  • 00762860105041 ()
  • 62860110504023 ()


  • Positive pressure airway secretion-clearing device

RESPICHAMBER* VHC with Mouthpiece - 00762860001138

RESPICHAMBER™ VHC with Mouthpiece
Trudell Medical International
101533
In Commercial Distribution

  • 10762860001135 ()
  • 00762860001138 ()


  • Medicine chamber spacer, reusable

RESTYLANE LYFT WITH LIDOCAINE - 08437027710087

RESTYLANE LYFT with Lidocaine is a sterile, biodegradable, transparent gel of stabilized hyaluronic acid of non-animal origin with the additon of lidocaine hydrochloride 0.3%. It is indicated in patients over the age of 21 for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds; for subcutaneous to supraperiosteal implantation for cheek augmentation and correction of age-related midface contour deficiencies; and for injection into the subcutaneous plane in the dorsal hand to correct volume deficit.
SAIMA GLOBAL FARMA S.L.
Gel 1 mL Syringe
In Commercial Distribution

  • 08437027710087 ()


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

3.2mm Drill with Stop - 00819251027441

3.2mm Drill with Stop
TOTAL JOINT ORTHOPEDICS, INC.
2009.00.000
In Commercial Distribution

  • 00819251027441 ()


  • Fluted surgical drill bit, reusable

Waveline ECO with CO2 - 00815871022774

No Description
Avante
6G001CO2
In Commercial Distribution

  • 00815871022774 ()


  • General-purpose multi-parameter bedside monitor

VA 13mm with Silicon - 07290108241105

No Description
WEST PHARMA. SERVICES IL, . LTD
8070314
In Commercial Distribution

  • 07290108241105 ()


  • Vial/bottle adaptor, hermetic

HME with Flex Tubes - M4853116117

A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.
MEDITERA TIBBI MALZEME SANAYI VE TICARET ANONIM SIRKETI
31161
In Commercial Distribution

  • M4853116128 ()
  • M4853116117 ()


  • Heat/moisture exchanger/microbial medical gas filter

ELMED INCORPORATED - 00198506083181

Epstein Abdominoplasty Retractor, 240x27mm blade with 60mm wide working end with teeth, with ergonomic handle,with Fiberoptic, with Suction
ELMED INCORPORATED
37322-26FS
In Commercial Distribution

  • 00198506083181 ()
37322-26FS

  • Hand-held surgical retractor, reusable
  • Fibreoptic retractor handle

Kitazato IUI Catheter with Outer Stiffener with Stylet Type3-v1 - 04580303269077

No Description
KITAZATO CORPORATION
121180 Type3-v1
In Commercial Distribution

  • 14580303269074 ()
  • 04580303269077 ()
121180

  • Assisted reproduction transfer catheter/set

Accu-Patch Conical Pellets with Tan Color Tape, with Latex - 04955114013193

50 units in single pack
SAKAMURA KENKYUSHO, K.K.
8010166
In Commercial Distribution

  • 04955114013193 ()


  • Ear microsystem seed/pellet

Mouse/Rabbit AmpliDetector Plus FITC with FluoroMounter with DAPI - B502BSB0358500

The AmpliDetector Plus FITC Kits are intended for the Immunofluorescent (IF) detection of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations.
BIO SB, INC.
BSB-0358-50
In Commercial Distribution

  • B502BSB0358500 ()

  • Total Volume: 50 Milliliter
BSB-0358-50

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Mouse/Rabbit AmpliDetector Plus FITC with FluoroMounter with DAPI - B502BSB0358150

The AmpliDetector Plus FITC Kits are intended for the Immunofluorescent (IF) detection of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations.
BIO SB, INC.
BSB-0358-15
In Commercial Distribution

  • B502BSB0358150 ()

  • Total Volume: 15 Milliliter
BSB-0358-15

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Mouse/Rabbit AmpliDetector Plus FITC with FluoroMounter with DAPI - B502BSB03581000

The AmpliDetector Plus FITC Kits are intended for the Immunofluorescent (IF) detection of antigens in paraffin-embedded tissue, cryostat sections, blood smears, cytosmears, and cell preparations.
BIO SB, INC.
BSB-0358-100
In Commercial Distribution

  • B502BSB03581000 ()

  • Total Volume: 100 Milliliter
BSB-0358-100

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Leica TP1020 (Single loading) With vaccum/ with fume control - 04049188089564

The instrument has been designed so that it is safe to use by the operator as well as for processing speci-mens—provided that it is operated according to these Instructions for Use. The Leica TP1020 is a modular automated tissue processor designed for the following laboratory applications: • Fixation • Dehydration • Paraffin infiltration of histological tissue specimens. The Leica TP1020 must be operated exclusively with the reagents listed in the IFU
Leica Biosystems Nussloch GmbH
000000014042230535
In Commercial Distribution

  • 04049188089564 ()

  • Device Size Text, specify:
14042230535

  • Tissue processor IVD, automated/semi-automated

Leica TP1020 (Double loading) With vacuum/ with fume control - 04049188088284

The instrument has been designed so that it is safe to use by the operator as well as for processing speci-mens—provided that it is operated according to these Instructions for Use. The Leica TP1020 is a modular automated tissue processor designed for the following laboratory applications: • Fixation • Dehydration • Paraffin infiltration of histological tissue specimens. The Leica TP1020 must be operated exclusively with the reagents listed in the IFU
Leica Biosystems Nussloch GmbH
000000014042231412
In Commercial Distribution

  • 04049188088284 ()

  • Device Size Text, specify:
14042231412

  • Tissue processor IVD, automated/semi-automated

Adult Cannula with 7ft Supply Tube - with Ear Cushions - 00848530061203

Adult Cannula with 7ft Supply Tube - with Ear Cushions
SUNSET HEALTHCARE SOLUTIONS, INC.
RES1107EC
In Commercial Distribution

  • 10848530061200 ()
  • 00848530061203 ()
RES1107EC

  • Nasal oxygen cannula, basic

MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMEDCOMP PRO-PICC WITH VALVE TECHNOLOGY - 00884908140163

6F X 60CM TRIPLE LUMEN6F X 60CM PRO-PICC®W/VALVE TECHNOLOGY BASICTECHNOLOGY BASIC LONG WIRE SETLONG WIRE SET
Medical Components, Inc.
MD82036302
Not in Commercial Distribution

  • 50884908140168 ()
  • 00884908140163 ()
MD82036302

  • Peripherally-inserted central venous catheter

MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMEDCOMP PRO-PICC WITH VALVE TECHNOLOGY - 00884908140132

5F X 55CM DUAL LUMEN5F X 55CM DU PRO-PICC®W/VALVE TECHNOLOGY BASICTECHNOLOGY BASIC LONG WIRE SETLONG WIRE SET
Medical Components, Inc.
MD82035202
Not in Commercial Distribution

  • 50884908140137 ()
  • 00884908140132 ()
MD82035202

  • Peripherally-inserted central venous catheter

MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMEDCOMP PRO-PICC WITH VALVE TECHNOLOGY - 00884908139433

5F X 55CM DUAL LUMEN5F X 55CM DU PRO-PICC®CT W/VALVE TECHNOLOGYTECHNOLOGY CATHETER ONLYCATHETER ONLY
Medical Components, Inc.
MD82035200
Not in Commercial Distribution

  • 50884908139438 ()
  • 00884908139433 ()
MD82035200

  • Peripherally-inserted central venous catheter

MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMEDCOMP PRO-PICC WITH VALVE TECHNOLOGY - 00884908139419

4F X 55CM SINGLE LUMEN PRO-PICC®CT W/VALVE TECHNOLOGY CATHETER ONLY
Medical Components, Inc.
MD82034100
Not in Commercial Distribution

  • 50884908139414 ()
  • 00884908139419 ()
MD82034100

  • Peripherally-inserted central venous catheter

MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMEDCOMP PRO-PICC WITH VALVE TECHNOLOGY - 00884908139303

5F X 60CM SINGLE LUMEN5F X 60CM PRO-PICC®CT W/VALVE TECHNOLOGY BASIC NURSINGTECHNOLO SETSET
Medical Components, Inc.
MD82035105
Not in Commercial Distribution

  • 50884908139308 ()
  • 00884908139303 ()
MD82035105

  • Peripherally-inserted central venous catheter

MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMEDCOMP PRO-PICC WITH VALVE TECHNOLOGY - 00884908137453

5F X 55CM DUAL LUMEN5F X 55CM DU PRO-PICC®CT W/VALVE TECHNOLOGY BASIC IR SETTECHNOLOG
Medical Components, Inc.
MD82035201
In Commercial Distribution

  • 50884908137458 ()
  • 00884908137453 ()
MD82035201

  • Peripherally-inserted central venous catheter

MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMEDCOMP PRO-PICC WITH VALVE TECHNOLOGY - 00884908137422

4F X 55CM SINGLE LUMEN4F X 55CM PRO-PICC®CT W/VALVE TECHNOLOGY BASIC IR SETTECHNOLOG
Medical Components, Inc.
MD82034101
In Commercial Distribution

  • 50884908137427 ()
  • 00884908137422 ()
MD82034101

  • Peripherally-inserted central venous catheter

MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMEDCOMP PRO-PICC WITH VALVE TECHNOLOGY - 00884908140170

5F X 55CM DUAL LUMEN5F X 55CM DU PRO-PICC®W/VALVE TECHNOLOGY BASICTECHNOLOGY BASIC LONG WIRE SETLONG WIRE SET
Medical Components, Inc.
MD82035222
Not in Commercial Distribution

  • 50884908140175 ()
  • 00884908140170 ()
MD82035222

  • Peripherally-inserted central venous catheter

MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMEDCOMP PRO-PICC WITH VALVE TECHNOLOGY - 00884908140149

5F X 60CM SINGLE LUMEN5F X 60CM PRO-PICC®W/VALVE TECHNOLOGY BASICTECHNOLOGY BASIC LONG WIRE SETLONG WIRE SET
Medical Components, Inc.
MD82035102
Not in Commercial Distribution

  • 50884908140144 ()
  • 00884908140149 ()
MD82035102

  • Peripherally-inserted central venous catheter

MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMEDCOMP PRO-PICC WITH VALVE TECHNOLOGY - 00884908140125

4F X 55CM SINGLE LUMEN PRO-PICC®W/VALVE TECHNOLOGY BASIC LONG WIRE SET
Medical Components, Inc.
MD82034102
Not in Commercial Distribution

  • 50884908140120 ()
  • 00884908140125 ()
MD82034102

  • Peripherally-inserted central venous catheter

MEDCOMP PRO-PICC WITH VALVE TECHNOLGOYMEDCOMP PRO-PICC WITH VALVE TECHNOLGOY - 00884908139440

6F X 60CM TRIPLE LUMEN6F X 60CM PRO-PICC®CT W/VALVE TECHNOLOGYTECHNOLOGY CATHETER ONLYCATHETER ONLY
Medical Components, Inc.
MD82036300
Not in Commercial Distribution

  • 50884908139445 ()
  • 00884908139440 ()
MD82036300

  • Peripherally-inserted central venous catheter

MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMEDCOMP PRO-PICC WITH VALVE TECHNOLOGY - 00884908139426

5F X 60CM SINGLE LUMEN5F X 60CM PRO-PICC®CT W/VALVE TECHNOLOGYTECHNOLOGY CATHETER ONLYCATHETER ONLY
Medical Components, Inc.
MD82035100
Not in Commercial Distribution

  • 50884908139421 ()
  • 00884908139426 ()
MD82035100

  • Peripherally-inserted central venous catheter

MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMEDCOMP PRO-PICC WITH VALVE TECHNOLOGY - 00884908139310

5F X 55CM DUAL LUMEN5F X 55CM DU PRO-PICC®CT W/VALVE TECHNOLOGY BASIC NURSINGTECHNOLO SETSET
Medical Components, Inc.
MD82035205
Not in Commercial Distribution

  • 50884908139315 ()
  • 00884908139310 ()
MD82035205

  • Peripherally-inserted central venous catheter

MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMEDCOMP PRO-PICC WITH VALVE TECHNOLOGY - 00884908139297

4F X 55CM SINGLE LUMEN PRO-PICC®CT W/VALVE TECHNOLOGY BASIC NURSING SET
Medical Components, Inc.
MD82034105
Not in Commercial Distribution

  • 50884908139292 ()
  • 00884908139297 ()
MD82034105

  • Peripherally-inserted central venous catheter

MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMEDCOMP PRO-PICC WITH VALVE TECHNOLOGY - 00884908137460

6F X 60CM TRIPLE LUMEN6F X 60CM PRO-PICC®CT W/VALVE TECHNOLOGY BASIC IR SETTECHNOLOG
Medical Components, Inc.
MD82036301
In Commercial Distribution

  • 50884908137465 ()
  • 00884908137460 ()
MD82036301

  • Peripherally-inserted central venous catheter

MEDCOMP PRO-PICC WITH VALVE TECHNOLOGYMEDCOMP PRO-PICC WITH VALVE TECHNOLOGY - 00884908137439

5F X 60CM SINGLE LUMEN5F X 60CM PRO-PICC®CT W/VALVE TECHNOLOGY BASIC IR SETTECHNOLOG
Medical Components, Inc.
MD82035101
In Commercial Distribution

  • 50884908137434 ()
  • 00884908137439 ()
MD82035101

  • Peripherally-inserted central venous catheter

Antibacterial Wound Dressing with Copper with Adhesive Contour #2 - 07290018406090

Copper impregnated antibactertial wound dressings designed to address a wide variety of wounds including: diabetic wounds, leg & foot ulcers, pressure ulcers, first & second degree burns, surgical wounds; venous and arterial ulcers. External Size 4" x 10". Internal pad size 2" x 8"
MEDCU TECHNOLOGIES LTD
2C-1025-01a
In Commercial Distribution

  • 07290018406311 ()
  • 07290018406090 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
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