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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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CARDINAL HEALTH - 10887488546872

CATARACT WITH TUBING PACK
Cardinal Health 200, LLC
SEY44CAASA
In Commercial Distribution

  • 50887488546870 ()
  • 10887488546872 ()
SEY44CAASA

  • Ophthalmic surgical procedure kit, medicated, single-use

CARDINAL HEALTH - 10887488200972

ANGIOPLASTY WITH STENT PACK
Cardinal Health 200, LLC
SCV41APPDF
In Commercial Distribution

  • 50887488200970 ()
  • 10887488200972 ()
SCV41APPDF

  • Angiography kit

Welly - 00372663171053

Bandages with TA ointment
WELLY HEALTH PBC
WLY1027
In Commercial Distribution

  • 00372663171053 ()


  • First aid kit, medicated

EON - 00366975013323

Eon Desensitizer with Glutaraldehyde
BENCO DENTAL SUPPLY CO.
5146-567
In Commercial Distribution

  • 00366975013323 ()


  • Dental coating, tooth-desensitizing

iLESSYS® - 04250337117360

Working Tube with handle
Joimax GmbH
WTS127507
In Commercial Distribution

  • 04250337117360 ()

  • L 125 mm / ID 6.5 mm / OD 7.5 mm
WTS127507

  • Endoscope sheath, reusable

iLESSYS® - 04250337110279

Working Tube with Handle
Joimax GmbH
WTS127007
In Commercial Distribution

  • 04250337110279 ()

  • L 124 mm / ID 6.0 mm / OD 7.0 mm
WTS127007

  • Endoscope sheath, reusable

T-handle - 04250337104841

T-Handle with Torque Limiter
Joimax GmbH
JMPS1022ST
In Commercial Distribution

  • 04250337104841 ()
JMPS1022ST

  • Surgical instrument handle, non-torque-limiting

CASSIOPEIA ACP - 08806395497980

Cervical Awl with Sleeve
GS Medical Co., Ltd.
GS142-0200
In Commercial Distribution

  • 08806395497980 ()
GS142-0200

  • Bone awl, reusable

Innospire Elegance - 00383730004112

ELEGANCE WITH SSR (RUSSIA)
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730004112 ()
1103294

  • Benchtop nebulizer, non-heated

Medline Industries, Inc. - 10888277082939

BASIN PACK WITH GOWNS
MEDLINE INDUSTRIES, INC.
DYNJ44070
In Commercial Distribution

  • 10888277082939 ()
DYNJ44070

  • General surgical procedure kit, non-medicated, reusable

Substrate Buffer - 10888234500711

For Use with PakPlus100
IMMUCOR GTI DIAGNOSTICS, INC.
404587
Not in Commercial Distribution

  • 10888234500711 ()
404587

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Specimen Diluent - 10888234500704

For Use with PakPlus100
IMMUCOR GTI DIAGNOSTICS, INC.
404582
Not in Commercial Distribution

  • 10888234500704 ()
404582

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Stopping Solution - 10888234500698

For Use with PakPlus100
IMMUCOR GTI DIAGNOSTICS, INC.
404585
Not in Commercial Distribution

  • 10888234500698 ()
404585

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Concentrated Wash (10X) - 10888234500681

For Use with PakPlus100
IMMUCOR GTI DIAGNOSTICS, INC.
404562
Not in Commercial Distribution

  • 10888234500681 ()
404562

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Cell Resuspension and Preservative Solution - 10888234500599

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404590
Not in Commercial Distribution

  • 10888234500599 ()
404590

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Anti-Human IgG/A/M Conjugate - 10888234500575

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404588
Not in Commercial Distribution

  • 10888234500575 ()
404588

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Normal Platelet Control (Negative Eluate Control) - 10888234500551

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404578
Not in Commercial Distribution

  • 10888234500551 ()
404578

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Negative Serum Control - 10888234500544

For Use with PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
404577
Not in Commercial Distribution

  • 10888234500544 ()
404577

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Negative Serum Control - 10888234500537

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404576
Not in Commercial Distribution

  • 10888234500537 ()
404576

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Negative Serum Control - 10888234500520

For Use with Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.
404574
Not in Commercial Distribution

  • 10888234500520 ()
404574

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Negative Serum Control - 10888234500513

For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404573
Not in Commercial Distribution

  • 10888234500513 ()
404573

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Negative Serum Control - 10888234500506

For Use with Pak12
IMMUCOR GTI DIAGNOSTICS, INC.
404572
Not in Commercial Distribution

  • 10888234500506 ()
404572

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Anti-Human IgG Conjugate - 10888234500469

For Use with Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.
404558
Not in Commercial Distribution

  • 10888234500469 ()
404558

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Anti-Human IgG Conjugate - 10888234500452

For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404557
Not in Commercial Distribution

  • 10888234500452 ()
404557

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

3 x 4% E-Gel 48 Gels - 10888234500667

For Use with ThromboType1
IMMUCOR GTI DIAGNOSTICS, INC.
EGEL48
In Commercial Distribution

  • 10888234500667 ()
EGEL48

  • Multiple human platelet antigen (HPA) typing IVD, kit, multiplex

PNPP Substrate - 10888234500650

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
403594
Not in Commercial Distribution

  • 10888234500650 ()
403594

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Serum Control - 10888234500643

For Use with PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
404601
Not in Commercial Distribution

  • 10888234500643 ()
404601

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Serum Control - 10888234500636

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404600
Not in Commercial Distribution

  • 10888234500636 ()
404600

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Serum Control - 10888234500629

For Use with Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.
404598
Not in Commercial Distribution

  • 10888234500629 ()
404598

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Serum Control - 10888234500612

For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404597
Not in Commercial Distribution

  • 10888234500612 ()
404597

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Serum Control - 10888234500605

For Use with Pak12
IMMUCOR GTI DIAGNOSTICS, INC.
404596
Not in Commercial Distribution

  • 10888234500605 ()
404596

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Platelet Control (Positive Eluate Control) - 10888234500568

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404579
Not in Commercial Distribution

  • 10888234500568 ()
404579

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Eluting Solution - 10888234500490

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404565
Not in Commercial Distribution

  • 10888234500490 ()
404565

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Buffering Solution - 10888234500476

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404560
Not in Commercial Distribution

  • 10888234500476 ()
404560

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

ELMED - 00842180172722

HANDLE WITH QUICK COUPLING
ELMED INCORPORATED
23-31143
In Commercial Distribution

  • 00842180172722 ()
23-31143

  • Arthroscopic surgical procedure kit, non-medicated, reusable

Cardioplegia Plus - 10887691000307

Filters with Solution Spike
HAEMONETICS CORPORATION
CPS02
In Commercial Distribution

  • 30887691000301 ()
  • 10887691000307 ()


  • Blood donor set, single-pack

NA - 10887587010403

FILE WITH HEX COUPLING
Synthes GmbH
03.500.020
In Commercial Distribution

  • H980035000200 ()
  • 10887587010403 ()
03500020

  • Bone file/rasp, manual, reusable

FENTEX - 04250407778378

Handle with suction control
FENTEX medical GmbH
270025FX
In Commercial Distribution

  • 04250407778378 ()
270025FX

  • Ear canal suction handle

Preparation tray, stainless steel - 04250381850169

with scale, 92x54 mm
Spiggle & Theis Medizintechnik GmbH
10-735-00
In Commercial Distribution

  • 04250381850169 ()
10-735-00

  • Surgical cutting/shaping board, reusable

Ceramco® 3 - D0013016050

With Powder Opaque Kit
Dentsply International Inc.
16 Shade Basic System
Not in Commercial Distribution

  • D0013016050 ()
301605

  • Dental appliance fabrication material, ceramic
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