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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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TIANLE - 06937572800124

Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-9813
In Commercial Distribution

  • 06937572800124 ()


  • Air-conduction hearing aid, wearable case

Medline Industries, Inc. - 10195327624859

STEWARD MINOR OPS PACK GSS
MEDLINE INDUSTRIES, INC.
DYNJ80912B
In Commercial Distribution

  • 40195327624850 ()
  • 10195327624859 ()
DYNJ80912B

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327624842

STEWARD OR THORACIC GSS
MEDLINE INDUSTRIES, INC.
DYNJ908538C
In Commercial Distribution

  • 10195327624842 ()
DYNJ908538C

  • General surgical procedure kit, non-medicated, single-use

TIANLE - 06937572800100

Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-9816
In Commercial Distribution

  • 06937572800100 ()


  • Air-conduction hearing aid, wearable case

TIANLE - 06937572800094

Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-9812
In Commercial Distribution

  • 06937572800094 ()


  • Air-conduction hearing aid, wearable case

Medline Industries, Inc. - 10195327624781

STEWARD SHOULDR ARTHRO GSS
MEDLINE INDUSTRIES, INC.
DYNJ908531B
In Commercial Distribution

  • 10195327624781 ()
DYNJ908531B

  • General surgical procedure kit, non-medicated, single-use

TIANLE - 06937572800070

Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-9822
In Commercial Distribution

  • 06937572800070 ()


  • Air-conduction hearing aid, wearable case

Medline Industries, Inc. - 10195327624767

STEWARD NEURO NHS PACK
MEDLINE INDUSTRIES, INC.
DYNJ82076B
In Commercial Distribution

  • 10195327624767 ()
DYNJ82076B

  • General surgical procedure kit, non-medicated, single-use

TIANLE - 06937572800056

Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-9818
In Commercial Distribution

  • 06937572800056 ()


  • Air-conduction hearing aid, wearable case

TIANLE - 06937572800049

Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-98
In Commercial Distribution

  • 06937572800049 ()


  • Air-conduction hearing aid, wearable case

Medline Industries, Inc. - 10195327624613

ANGIOGRAPHY DRAPE PACK
MEDLINE INDUSTRIES, INC.
DYNJ17133K
In Commercial Distribution

  • 40195327624614 ()
  • 10195327624613 ()
DYNJ17133K

  • General surgical procedure kit, non-medicated, single-use

TIANLE - 06937572800025

Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-95
In Commercial Distribution

  • 06937572800025 ()


  • Air-conduction hearing aid, wearable case

TIANLE - 06937572800018

Body-worn Hearing Aid
Zhongshan Tianle Hearing Technology Co., Ltd.
HA-93
In Commercial Distribution

  • 06937572800018 ()


  • Air-conduction hearing aid, wearable case

Steawoce - 06937359412366

No Description
Wuhan Sitaili Medical Apparatus Development Co., Ltd.
A-3061
In Commercial Distribution

  • 06937359412366 ()


  • Ostomy bag protector

FirstCheck HOME DRUG TEST - 06936983177689

REF: ABTDOAO17701A, FDA OTC, 1T/kit, AMP500/COC150/FYL1/MDMA500/MET500/MOP300/THC50
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983177689 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Medline Industries, Inc. - 10195327624545

TOTAL KNEE
MEDLINE INDUSTRIES, INC.
DYNJ908896C
In Commercial Distribution

  • 10195327624545 ()
DYNJ908896C

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327624538

ARTHROSCOPY PACK
MEDLINE INDUSTRIES, INC.
DYNJ86367
In Commercial Distribution

  • 40195327624539 ()
  • 10195327624538 ()
DYNJ86367

  • General surgical procedure kit, non-medicated, single-use

FirstCheck HOME DRUG TEST - 06936983177238

ABTDOAO16701A, 1T/kit, AMP500/COC150/FYL1/MET500/MOP300/THC50
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983177238 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Medline Industries, Inc. - 10195327624514

EXTREMITY PACK
MEDLINE INDUSTRIES, INC.
DYNJ86368
In Commercial Distribution

  • 40195327624515 ()
  • 10195327624514 ()
DYNJ86368

  • General surgical procedure kit, non-medicated, single-use

Shinetell Digital Pregnancy Test - 06936983167116

1T, FDA OTC
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983167116 ()


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

Medline Industries, Inc. - 10195327624491

TOTAL HIP/BIPOLAR HIP
MEDLINE INDUSTRIES, INC.
CDS982561K
In Commercial Distribution

  • 10195327624491 ()
CDS982561K

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327624460

TOTAL KNEE
MEDLINE INDUSTRIES, INC.
DYNJ910316
In Commercial Distribution

  • 10195327624460 ()
DYNJ910316

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327624453

TOTAL SHOULDER PACK
MEDLINE INDUSTRIES, INC.
DYNJ910317
In Commercial Distribution

  • 40195327624454 ()
  • 10195327624453 ()
DYNJ910317

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327624446

TOTAL HIP PACK
MEDLINE INDUSTRIES, INC.
DYNJ910315
In Commercial Distribution

  • 10195327624446 ()
DYNJ910315

  • General surgical procedure kit, non-medicated, single-use

Multi-Drug 14 Drugs Rapid Test Cup - 06936983165471

FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 16936983165478 ()
  • 06936983165471 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Medline Industries, Inc. - 10195327624422

MVR PACK
MEDLINE INDUSTRIES, INC.
DYNJ910314
In Commercial Distribution

  • 10195327624422 ()
DYNJ910314

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327624415

KNEE ARTHROSCOPY PACK
MEDLINE INDUSTRIES, INC.
DYNJ55736C
In Commercial Distribution

  • 40195327624416 ()
  • 10195327624415 ()
DYNJ55736C

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10195327624408

ACL PACK
MEDLINE INDUSTRIES, INC.
DYNJ29175G
In Commercial Distribution

  • 40195327624409 ()
  • 10195327624408 ()
DYNJ29175G

  • General surgical procedure kit, non-medicated, single-use

Alltest Multi-Drug 12 Drugs Rapid Test Cup - 06936983165440

FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/OXY100/FYL1
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 16936983165447 ()
  • 06936983165440 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Multi-Drug 13 Drugs Rapid Test Cup - 06936983165419

FDA Clia Waived, AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50/FYL1
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 16936983165416 ()
  • 06936983165419 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Medline Industries, Inc. - 10195327624316

CAROTID PACK
MEDLINE INDUSTRIES, INC.
DYNJ910312
In Commercial Distribution

  • 40195327624317 ()
  • 10195327624316 ()
DYNJ910312

  • General surgical procedure kit, non-medicated, single-use

Alltest Pregnancy Rapid Test - 06936983155151

1T, FDA OTC, Without Absorbent wick
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983155151 ()


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

Medline Industries, Inc. - 10195327624293

FOOT ANKLE PACK
MEDLINE INDUSTRIES, INC.
DYNJ86363
In Commercial Distribution

  • 40195327624294 ()
  • 10195327624293 ()
DYNJ86363

  • General surgical procedure kit, non-medicated, single-use

Identify Fentanyl Rapid Cassette - 06936983149426

1T,EN,FDA, OTC,1ng
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102H A3218
In Commercial Distribution

  • 06936983149426 ()
ID-AT1-DIP-FEN-1-AZ1

  • Fentanyl IVD, kit, rapid ICT, clinical

Medline Industries, Inc. - 10195327624279

ANESTHESIA CIRCUIT ADULT-LF
MEDLINE INDUSTRIES, INC.
DYNJAAF6916
In Commercial Distribution

  • 40195327624270 ()
  • 10195327624279 ()
DYNJAAF6916

  • General surgical procedure kit, non-medicated, single-use

Discover Fentanyl Rapid Tes Cassette - 06936983148504

1T, cut-off:1ng/ml,FDA OTC
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102H A1617
In Commercial Distribution

  • 06936983148504 ()
DISP-FY-102H

  • Fentanyl IVD, kit, rapid ICT, clinical

Alltest - 06936983144650

Fentanyl Urine Test Cassette, 1T*6,FDA, OTC,1ng
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102H
In Commercial Distribution

  • 06936983144650 ()
  • 06936983143950 ()


  • Fentanyl IVD, kit, rapid ICT, clinical

AllTest - 06936983144568

AllTest Fentanyl Urine Test Cassette, 25T (for FDA Clia Waived)1ng, White pouch
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102C (1ng)
In Commercial Distribution

  • 06936983144551 ()
  • 06936983144568 ()


  • Fentanyl IVD, kit, rapid ICT, clinical

Medline Industries, Inc. - 10195327624200

AVR PACK
MEDLINE INDUSTRIES, INC.
DYNJ906343G
In Commercial Distribution

  • 10195327624200 ()
DYNJ906343G

  • General surgical procedure kit, non-medicated, single-use

Alltest - 06936983143950

Fentanyl Urine Test Cassette, 1T,FDA, OTC,1ng
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102H
In Commercial Distribution

  • 06936983143950 ()


  • Fentanyl IVD, kit, rapid ICT, clinical

AllTest Fentanyl Rapid Test (Urine) - 06936983138642

25T, 1ng,white package
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102
In Commercial Distribution

  • 06936983138857 ()
  • 06936983138642 ()


  • Fentanyl IVD, kit, rapid ICT, clinical

AllTest Fentanyl Rapid Test (Urine) - 06936983136495

25T, 1ng
Hangzhou AllTest Biotech Co., Ltd.
DFY-A102
In Commercial Distribution

  • 06936983136495 ()
  • 06936983138840 ()


  • Fentanyl IVD, kit, rapid ICT, clinical

Medline Industries, Inc. - 10195327624163

KNEE PACK
MEDLINE INDUSTRIES, INC.
DYNJ49823G
In Commercial Distribution

  • 40195327624164 ()
  • 10195327624163 ()
DYNJ49823G

  • General surgical procedure kit, non-medicated, single-use

Huibo Medical - 06936943412416

Mainly applied to superficial wounds with much exudates. 1) first and second degree burn; 2) skin abrasion; 3)be used as second degree dressing when combining with wound fillings
Henan Huibo Medical Co.,Ltd.
10*10cm, borderless
In Commercial Distribution

  • 06936943412416 ()
  • 06936943412430 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial

Medline Industries, Inc. - 10195327624149

CATARACT PACK
MEDLINE INDUSTRIES, INC.
DYNJ81329A
In Commercial Distribution

  • 40195327624140 ()
  • 10195327624149 ()
DYNJ81329A

  • General surgical procedure kit, non-medicated, single-use

Huibo Medical - 06936943411846

prevent and treat mild varicose veins, 70% nylon, 30% spandex. Graduated compression from ankle upwards.
Henan Huibo Medical Co.,Ltd.
I-AD-M, Beige, Open toe
In Commercial Distribution

  • 06936943411846 ()


  • Compression/pressure sock/stocking, reusable

Medline Industries, Inc. - 10195327624125

TOTAL KNEE CDS
MEDLINE INDUSTRIES, INC.
CDS982559K
In Commercial Distribution

  • 10195327624125 ()
CDS982559K

  • General surgical procedure kit, non-medicated, single-use

Huibo Medical - 06936943411488

Applied to operative and surgical wounds or indwelling catheter; be used as infants’ umbilical cord wound dressing
Henan Huibo Medical Co.,Ltd.
10*10cm
In Commercial Distribution

  • 06936943411488 ()
  • 06936943411495 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

Medline Industries, Inc. - 10195327624064

DR SMITH HAND PACK
MEDLINE INDUSTRIES, INC.
DYNJ56600C
In Commercial Distribution

  • 40195327624065 ()
  • 10195327624064 ()
DYNJ56600C

  • General surgical procedure kit, non-medicated, single-use

Huibo Medical - 06936943411457

Medical skin stretching and secure wound-closure system comprises PP buckle, medical adhesive tape and release paper.
Henan Huibo Medical Co.,Ltd.
25*10mm
In Commercial Distribution

  • 06936943411457 ()


  • Skin-closing tension device
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