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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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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

Antibacterial Wound Dressing with Copper with Adhesive Contour #1 - 07290018406076

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 4". Internal pad size 2" x 2.2"
MEDCU TECHNOLOGIES LTD
2C-0505-01a
In Commercial Distribution

  • 07290018406298 ()
  • 07290018406076 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial

Medline - 10080196152575

DRAPE, ROBOTICS, WITH LEGGINGS, WITH POU
MEDLINE INDUSTRIES, INC.
DYNJP9108
In Commercial Distribution

  • 40080196152576 ()
  • 10080196152575 ()
DYNJP9108

  • Patient surgical drape, single-use

Speedlock - 00848657002998

Grasper, 5mm with spoon with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8510-21-R
In Commercial Distribution

  • 00848657002998 ()


  • Rigid endoscopic tissue manipulation forceps, reusable

Omnicap - 08056646507696

Surgical cap with ties (with motif)
OMNIA SRL
10.M0030.00
In Commercial Distribution

  • 08056646507702 ()
  • 08056646507696 ()


  • Surgical cap, single-use

RELIANCE LITe - 07613327265958

SUCTION TIP WITH BEND, WITH LIP
Stryker Corporation
48245002
In Commercial Distribution

  • 07613327265958 ()
48245002

  • Bone lever/elevator, reusable

uNion Cervical Plate System - 00814386029971

Awl with Stop, with strike cap
Ulrich Medical Usa, Inc.
UU994-47-02
In Commercial Distribution

  • 00814386029971 ()
UU994-47-02

  • Spinal fixation plate, non-bioabsorbable

CAPI 3 NEONAT Hb - 03607360025062

No Description
SEBIA
2506
In Commercial Distribution

  • 03607360025062 ()
2506

  • Multiple haemoglobin subtype IVD, kit, electrophoresis

BD BACTEC™ Myco/F Lytic Culture Vials - 00382904422882

BD BACTEC™ Myco/F Lytic Culture Vials
BECTON, DICKINSON AND COMPANY
442288
In Commercial Distribution

  • 00382904422882 ()
  • 30382904422883 ()
442288

  • Culture medium antimicrobial supplement IVD

BD BBL™ Desoxycholate Reagent Droppers - 30382902611838

BD BBL™ Desoxycholate Reagent Droppers
BECTON, DICKINSON AND COMPANY
261183
In Commercial Distribution

  • 30382902611838 ()
  • 00382902611837 ()

  • Total Volume: 0.5 Milliliter
261183

  • Bile solubility microbial reagent IVD

MaxZero - 10885403242083

Pressure rated extension set, IV connector 18 cm (7.0 in)
BD Switzerland Sàrl
MZ5309
In Commercial Distribution

  • 10885403242083 ()
  • 50885403242081 ()

  • Length: 7.0 Inch
MZ5309

  • Intravenous administration tubing extension set
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