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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Alinity i Folate Calibrators
ABBOTT IRELAND
08P1402
In Commercial Distribution

  • 00380740136536 ()
08P1402

  • Folate (vitamin B9) IVD, calibrator
Alinity i T-Uptake Controls
Abbott Ireland Diagnostics
08P1210
In Commercial Distribution

  • 00380740135478 ()
08P1210

  • Multiple thyroid hormone uptake (T-uptake) IVD, control
Alinity i HE4 Controls
Abbott GmbH
08P5010
In Commercial Distribution

  • 00380740135423 ()
08P5010

  • Human epididymis protein 4 (HE4) IVD, control
Alinity i DHEA-S Controls
Abbott GmbH
09P3710
In Commercial Distribution

  • 00380740150631 ()
09P3710

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control
Alinity i DHEA-S Calibrators
Abbott GmbH
09P3701
In Commercial Distribution

  • 00380740150624 ()
09P3701

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, calibrator
Alinity i Anti-TPO Controls
Abbott Ireland Diagnostics
09P3510
In Commercial Distribution

  • 00380740150600 ()
09P3510

  • Multiple thyroid antibody IVD, control
Alinity i Anti-TPO Calibrators
Abbott Ireland Diagnostics
09P3501
In Commercial Distribution

  • 00380740150594 ()
09P3501

  • Multiple thyroid antibody IVD, calibrator
Alinity i Anti-Tg Controls
Abbott Ireland Diagnostics
09P3410
In Commercial Distribution

  • 00380740150587 ()
09P3410

  • Thyroglobulin antibody IVD, control
Alinity i Anti-Tg Calibrators
Abbott Ireland Diagnostics
09P3401
In Commercial Distribution

  • 00380740150570 ()
09P3401

  • Thyroglobulin antibody IVD, calibrator
Alinity i Anti-HBs Calibrators
Abbott Ireland Diagnostics
07P8801
In Commercial Distribution

  • 00380740149574 ()
07P8801

  • Hepatitis B virus surface total antibody IVD, calibrator
Alinity i B12 Controls
ABBOTT IRELAND
07P6712
In Commercial Distribution

  • 00380740136680 ()
07P6712

  • Vitamin B12 IVD, control
Alinity i B12 Calibrators
ABBOTT IRELAND
07P6702
In Commercial Distribution

  • 00380740136673 ()
07P6702

  • Vitamin B12 IVD, calibrator
Alinity i Anti-HBc Controls
Abbott GmbH
07P8410
In Commercial Distribution

  • 00380740136642 ()
07P8410

  • Hepatitis B virus core total antibody IVD, control
Alinity i Anti-HBc Calibrator
Abbott GmbH
07P8401
In Commercial Distribution

  • 00380740136635 ()
07P8401

  • Hepatitis B virus core total antibody IVD, calibrator
Alinity i Folate Controls
ABBOTT IRELAND
08P1412
In Commercial Distribution

  • 00380740136543 ()
08P1412

  • Folate (vitamin B9) IVD, control
Alinity i FSH Controls
ABBOTT IRELAND
07P4910
In Commercial Distribution

  • 00380740131623 ()
07P4910

  • Follicle stimulating hormone (FSH) IVD, control
Alinity i FSH Calibrators
ABBOTT IRELAND
07P4901
In Commercial Distribution

  • 00380740131616 ()
07P4901

  • Follicle stimulating hormone (FSH) IVD, calibrator
Alinity i T-Uptake Calibrators
Abbott Ireland Diagnostics
08P1201
In Commercial Distribution

  • 00380740131531 ()
08P1201

  • Multiple thyroid hormone uptake (T-uptake) IVD, calibrator
Alinity i Ferritin Controls
ABBOTT IRELAND
07P6510
In Commercial Distribution

  • 00380740131463 ()
07P6510

  • Ferritin IVD, control
Alinity i Ferritin Calibrators
ABBOTT IRELAND
07P6501
In Commercial Distribution

  • 00380740131456 ()
07P6501

  • Ferritin IVD, calibrator
Alinity i TSH Controls
ABBOTT IRELAND
07P4810
In Commercial Distribution

  • 00380740131135 ()
07P4810

  • Thyroid stimulating hormone (TSH) IVD, control
Alinity i TSH Calibrators
ABBOTT IRELAND
07P4801
In Commercial Distribution

  • 00380740131128 ()
07P4801

  • Thyroid stimulating hormone (TSH) IVD, calibrator
Alinity i HE4 Calibrators
Abbott GmbH
08P5001
In Commercial Distribution

  • 00380740131067 ()
08P5001

  • Human epididymis protein 4 (HE4) IVD, calibrator
Alinity i CEA Controls
Abbott Ireland Diagnostics
07P6210
In Commercial Distribution

  • 00380740130848 ()
07P6210

  • Carcinoembryonic antigen (CEA) IVD, control
Alinity i CEA Calibrators
Abbott Ireland Diagnostics
07P6201
In Commercial Distribution

  • 00380740130831 ()
07P6201

  • Carcinoembryonic antigen (CEA) IVD, calibrator
Alinity i AFP Controls
Abbott Ireland Diagnostics
07P9010
In Commercial Distribution

  • 00380740130800 ()
07P9010

  • Alpha-fetoprotein (AFP) IVD, control
CENTRAL LINE I PACK
Cardinal Health 200, LLC
SCV73CLCEA
In Commercial Distribution

  • 50888439446140 ()
  • 10888439446142 ()
SCV73CLCEA

  • Cardiothoracic surgical procedure kit, medicated, single-use
VASCULAR CARE PACK I
Cardinal Health 200, LLC
SBA13LOEMG
In Commercial Distribution

  • 50888439383919 ()
  • 10888439383911 ()
SBA13LOEMG

  • Cervical anaesthesia kit
HFHS CRANIOTOMY PACK I
Cardinal Health 200, LLC
SNEW1CRHFN
In Commercial Distribution

  • 50888439415795 ()
  • 10888439415797 ()
SNEW1CRHFN

  • Craniotomy kit
MINOR SET-UP I PLUS-LF
MEDLINE INDUSTRIES, INC.
DYNJS0103
In Commercial Distribution

  • 10080196800292 ()
  • 40080196800293 ()
DYNJS0103

  • General surgical procedure kit, non-medicated, reusable
PACK,LITHOTOMY,PK I
MEDLINE INDUSTRIES, INC.
DYNJP9000
In Commercial Distribution

  • 40080196736059 ()
  • 10080196736058 ()
DYNJP9000

  • General surgical procedure kit, non-medicated, single-use
G.O. R. I PACK
MEDLINE INDUSTRIES, INC.
DYNJ19944A
In Commercial Distribution

  • 10080196659012 ()
  • 40080196659013 ()
DYNJ19944A

  • General surgical procedure kit, non-medicated, single-use
KNEE ARTHROSCOPY PACK I
Cardinal Health 200, LLC
SOP31KAMNL
In Commercial Distribution

  • 50888439346167 ()
  • 10888439346169 ()
SOP31KAMNL

  • Arthroscopic surgical procedure kit, medicated
16mm I Rigid Plate
OSTEOMED LLC
210-0235
In Commercial Distribution

  • 00845694001830 ()

  • Length: 16 Millimeter
210-0235

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
4 Hole I Plate
OSTEOMED LLC
213-0013
In Commercial Distribution

  • 00845694002981 ()

  • Length: 14 Millimeter
213-0013

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
DBD-PACK,SHOULDER I,SIRUS
MEDLINE INDUSTRIES, INC.
DYNJP8400S
In Commercial Distribution

  • 40080196309109 ()
  • 10080196309108 ()
DYNJP8400S

  • Surgical/examination garment kit
DBD-PACK,HIP I,SIRUS
MEDLINE INDUSTRIES, INC.
DYNJP8200S
In Commercial Distribution

  • 40080196748823 ()
  • 40080196915119 ()
  • 10080196309030 ()
DYNJP8200S

  • Patient surgical drape, single-use
PACK,ARTHROSCOPY I,SIRUS
MEDLINE INDUSTRIES, INC.
DYNJP8100S
In Commercial Distribution

  • 40080196308997 ()
  • 10080196308996 ()
DYNJP8100S

  • Arthroscopic surgical procedure kit, non-medicated, single-use
HFHS CRANIOTOMY PACK I
Cardinal Health 200, LLC
SNEW1CRHFL
In Commercial Distribution

  • 50888439114490 ()
  • 10888439114492 ()
SNEW1CRHFL

  • Craniotomy kit
HEAD AND NECK I
Cardinal Health 200, LLC
SEN35HNSSC
In Commercial Distribution

  • 50887488973645 ()
  • 10887488973647 ()
SEN35HNSSC

  • General surgical procedure kit, non-medicated, single-use
CV I II,KIT
Cardinal Health 200, LLC
PC23OHRMO
In Commercial Distribution

  • 50887488811954 ()
  • 10887488811956 ()
PC23OHRMO

  • Cardiothoracic surgical procedure kit, medicated, single-use
STERILE I R PACK
Cardinal Health 200, LLC
SBA54IRSIA
In Commercial Distribution

  • 50887488844006 ()
  • 10887488844008 ()
SBA54IRSIA

  • General surgical procedure kit, medicated
STERILE KAIR I PACK
Cardinal Health 200, LLC
SAN45SAKP2
In Commercial Distribution

  • 50887488830238 ()
  • 10887488830230 ()
SAN45SAKP2

  • Angiography kit
STERILE I D TRAY
Cardinal Health 200, LLC
08-2661A
In Commercial Distribution

  • 50887488819585 ()
  • 10887488819587 ()
08-2661A

  • General surgical procedure kit, medicated
STERILE I D TRAY
Cardinal Health 200, LLC
08-4490C
In Commercial Distribution

  • 50887488868156 ()
  • 10887488868158 ()
08-4490C

  • General surgical procedure kit, medicated
KP SURE SET I
MEDLINE INDUSTRIES, INC.
DYNJKPSS01
In Commercial Distribution

  • 10888277545434 ()
  • 40888277545435 ()
DYNJKPSS01

  • General surgical procedure kit, non-medicated, reusable
KIT,I AND D
Cardinal Health 200, LLC
PGMHIDBHG
In Commercial Distribution

  • 50887488742319 ()
  • 10887488742311 ()
PGMHIDBHG

  • General surgical procedure kit, medicated
STERILE CYSTOSCOPY PACK I
Cardinal Health 200, LLC
SBA7CCYYNC
In Commercial Distribution

  • 50887488762966 ()
  • 10887488762968 ()
SBA7CCYYNC

  • Urological surgical procedure kit, non-medicated, single-use
STERILE EYE I PACK
Cardinal Health 200, LLC
SEY35EYSSC
In Commercial Distribution

  • 50887488752196 ()
  • 10887488752198 ()
SEY35EYSSC

  • Ophthalmic surgical procedure kit, non-medicated, single-use
STERILE HAND I PACK
Cardinal Health 200, LLC
SOP69HDSPA
In Commercial Distribution

  • 50887488601975 ()
  • 10887488601977 ()
SOP69HDSPA

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