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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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Neuro Cochlear Implant System - 03663227001952

CI-Link exchange
NEURELEC
178378
In Commercial Distribution

  • 03663227001952 ()


  • Hearing aid/implant system programming interface unit

The Magnet™ - 08714729146841

Exchange Device
BOSTON SCIENTIFIC CORPORATION
H74908966011
In Commercial Distribution

  • 08714729146841 ()


  • Catheter-exchange guidewire holder

Lunderquist - 00827002285651

Lunderquist, Exchange
COOK INCORPORATED
G28565
In Commercial Distribution

  • 00827002285651 ()
SF-38-145-LUND

  • Gastro-urological guidewire, single-use

Lunderquist - 00827002285644

Lunderquist, Exchange
COOK INCORPORATED
G28564
In Commercial Distribution

  • 00827002285644 ()
SF-38-120-LUND

  • Gastro-urological guidewire, single-use

Lunderquist - 00827002285620

Lunderquist, Exchange
COOK INCORPORATED
G28562
In Commercial Distribution

  • 00827002285620 ()
SF-32-120-LUND

  • Gastro-urological guidewire, single-use

PediNail - 00841132144282

EXCHANGE TUBE
ORTHOPEDIATRICS CORP.
11-1500-0004
In Commercial Distribution

  • 00841132144282 ()
11-1500-0004

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Trapper™ - 00191506048938

Exchange Device
BOSTON SCIENTIFIC CORPORATION
H74939739130
In Commercial Distribution

  • 00191506048938 ()
H74939739130

  • Coronary angioplasty balloon catheter, basic

General Instrument - 00841132128626

Exchange Tube
ORTHOPEDIATRICS CORP.
11-1500-005
In Commercial Distribution

  • 00841132128626 ()
11-1500-005

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Spectra Optia® - 05020583122208

Exchange Sets
TERUMO BCT, INC.
12220
In Commercial Distribution

  • 05020583122208 ()
  • 35020583122209 ()


  • Apheresis system tubing set

Spectra Optia® - 05020583102200

Exchange Set
TERUMO BCT, INC.
10220
In Commercial Distribution

  • 05020583102200 ()
  • 35020583102201 ()
10220

  • Apheresis system tubing set

AMPLATZER™ - 00811806010663

Exchange System
AGA MEDICAL CORPORATION
9-EITV12F45/80
In Commercial Distribution

  • 00811806010663 ()

  • Catheter Gauge: 12 French
9-EITV12F45/80

  • Cardiac occluder delivery kit

AMPLATZER™ - 00811806010649

Exchange System
AGA MEDICAL CORPORATION
9-EITV09F45/80
In Commercial Distribution

  • 00811806010649 ()

  • Catheter Gauge: 9 French
9-EITV09F45/80

  • Cardiac occluder delivery kit

AMPLATZER™ - 00811806010632

Exchange System
AGA MEDICAL CORPORATION
9-EITV08F180/80
In Commercial Distribution

  • 00811806010632 ()

  • Catheter Gauge: 8 French
9-EITV08F180/80

  • Cardiac occluder delivery kit

AMPLATZER™ - 00811806010625

Exchange System
AGA MEDICAL CORPORATION
9-EITV06F180/80
In Commercial Distribution

  • 00811806010625 ()

  • Catheter Gauge: 6 French
9-EITV06F180/80

  • Cardiac occluder delivery kit

OptiMesh Multiplanar Expandable Interbody Fusion System - M7403150001

Exchange Tube
SPINEOLOGY INC.
32-28-005
In Commercial Distribution

  • M7403150001 ()
315-0001

  • Orthopaedic prosthesis implantation positioning instrument, single-use

EXCHANGE TUBE - 00848665002669

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0809
In Commercial Distribution

  • 00848665002669 ()


  • Orthopaedic implantation hammering attachment

Rapid Exchange - 08714729301905

XL Cannula
BOSTON SCIENTIFIC CORPORATION
M00545820
In Commercial Distribution

  • 08714729301905 ()

  • 5.5 F Diameter
  • 1.8 mm Diameter


  • ERCP catheter, non-balloon, non-electrical, single-use

Exchange Select - 00614299999152

First Aid Kit, First Aid Essentials, 70 items including 1 carrying case: 15 - Fabric Antibacterial Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 10 - Fabric Antibacterial Bandages 3/4 IN x 3 IN (19 mm x 76mm); 5 - Fabric Antibacterial Bandages 1 IN x 3 IN (25 mm x 76 mm); 21 - Sheer Antibacterial Bandages 1 IN x 3 IN (25mm x 76 mm); 6 - Hand Cleansing Wipes 4.75 IN x 7.75 IN (120 mm x 196 mm); 4 - Triple Antibiotic Ointment 1/32 OZ (0.9 g); 8 - Sterile Pads 2 IN x 2 IN (50 mm x 50 mm); 1 - Carrying Case
Aafes
614299999152
In Commercial Distribution

  • 10614299999159 ()
  • 00614299999152 ()
  • 20614299999156 ()


  • First aid kit, medicated

Exchange Select - 00614299896338

Variety Pack, Antibacterial Assorted sizes: Flexible Fabric 3/4 IN x 3 IN (19 mm x 76 mm); Clear Watershield 1 IN x 2 1/2 IN (25 mm x 63 mm); 3/4 IN x 3 IN (19 mm x 76 mm); Strong Strip Watershield 1 IN x 3 1/4 (25 mm x 82 mm)
Aafes
614299896338
In Commercial Distribution

  • 10614299896335 ()
  • 00614299896338 ()
  • 60614299896330 ()


  • Skin-cover adhesive strip, antimicrobial

Exchange Select - 00614299896291

Hydrogel Burns Pads, all one size, 1.9 IN x 2.95 IN (49 mm x 74mm)
Aafes
614299896291
In Commercial Distribution

  • 10614299896298 ()
  • 00614299896291 ()
  • 60614299896293 ()


  • Wound hydrogel dressing, non-antimicrobial

Exchange Select - 00614299802933

Smart-Flex Antibacterial Adhesive Bandages, all one size, 2 3/4 in x 3 1/2 in (70 mm x 89 mm)
Aafes
614299802933
In Commercial Distribution

  • 10614299802930 ()
  • 00614299802933 ()
  • 60614299802935 ()


  • Skin-cover adhesive strip, antimicrobial

Exchange Select - 00614299725867

Smart-Flex Antibacterial Adhesive Bandages, assorted sizes, 5/8 in x 2 1/4 in (16 mm x 57 mm); 7/8 in x 2 3/4 (22 mm x 69 mm); 1 1/8 in x 2 5/8 in (29 mm x 68 mm)
Aafes
614299725867
Not in Commercial Distribution

  • 10614299725864 ()
  • 00614299725867 ()
  • 60614299725869 ()


  • Skin-cover adhesive strip, antimicrobial

Exchange Select - 00614299725690

Paint Splatter Antibacterial Adhesive Bandages, all one size, assorted designs, 3/4 in x 3 in (19 mm x 76 mm)
Aafes
614299725690
Not in Commercial Distribution

  • 10614299725697 ()
  • 00614299725690 ()
  • 60614299725692 ()


  • Skin-cover adhesive strip, antimicrobial

Exchange Select - 00614299668645

Drug Free Nasal Strips Tan Extra Strength
Aafes
614299668645
In Commercial Distribution

  • 10614299668642 ()
  • 00614299668645 ()
  • 60614299668647 ()


  • Nasal breathing aid, external

Exchange Select - 00614299668638

Drug Free Nasal Strips Clear Extra Strength
Aafes
614299668638
In Commercial Distribution

  • 10614299668635 ()
  • 00614299668638 ()
  • 60614299668630 ()


  • Nasal breathing aid, external

Exchange Select - 00614299437388

Exchange Select DPS +/-Blue Cap
SPD SWISS PRECISION DIAGNOSTICS GMBH
One Step Pregnancy Test
Not in Commercial Distribution

  • 10614299437385 ()
  • 00614299437388 ()
  • 00633472000133 ()


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

Exchange Select - 00614299405424

Sheer Antibacterial Adhesive Bandages, 3 in x 4 in (76 mm x 101 mm)
Aafes
614299405424
In Commercial Distribution

  • 10614299405421 ()
  • 00614299405424 ()
  • 60614299405426 ()


  • Adhesive bandage

Exchange Select - 00614299405417

Extra Large Flexible Fabric Antibacterial Adhesive Bandages, 2 in x 4 in (50 mm x 101 mm)
Aafes
614299405417
In Commercial Distribution

  • 10614299405414 ()
  • 00614299405417 ()
  • 60614299405419 ()


  • Skin-cover adhesive strip, antimicrobial

Exchange Select - 00614299405400

Non-Stick Pads, all one size, 3 in x 4 in (76 mm x 101 mm)
Aafes
614299405400
In Commercial Distribution

  • 10614299405407 ()
  • 00614299405400 ()
  • 60614299405402 ()


  • Non-woven gauze pad

Exchange Select - 00614299405394

Sterile Pads, all one size, 2 in x 2 in (50 mm x 50 mm)
Aafes
614299405394
In Commercial Distribution

  • 10614299405391 ()
  • 00614299405394 ()
  • 60614299405396 ()


  • Non-woven gauze pad
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