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 HBsAg Next Confirmatory Reagent Kit (200T)
Abbott Ireland Diagnostics
01R6521
In Commercial Distribution

  • 00380740161262 ()
01R6521

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Alinity i Total B-hCG Reagent Kit 1200 Tests
ABBOTT IRELAND
07P5131
In Commercial Distribution

  • 00380740160623 ()
07P5131

  • Human chorionic gonadotropin beta-core fragment IVD, kit, chemiluminescent immunoassay
Alinity i HBsAg Next Qualitative Reagent Kit (1200T)
Abbott Ireland Diagnostics
01R6431
In Commercial Distribution

  • 00380740160593 ()
01R6431

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Alinity i HBsAg Next Qualitative Reagent Kit (200T)
Abbott Ireland Diagnostics
01R6421
In Commercial Distribution

  • 00380740160579 ()
01R6421

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Alinity i Free PSA Reagent Kit 1000 Tests
Abbott Ireland Diagnostics
07P9331
In Commercial Distribution

  • 00380740158347 ()
07P9331

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Alinity i Free PSA Reagent Kit 200 Tests
Abbott Ireland Diagnostics
07P9321
In Commercial Distribution

  • 00380740158330 ()
07P9321

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Alinity i Total PSA Reagent Kit 200 Tests
Abbott Ireland Diagnostics
07P9221
In Commercial Distribution

  • 00380740158316 ()
07P9221

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
Alinity i BRAHMS PCT Reagent Kit 200 Tests
Abbott Ireland Diagnostics
01R1821
In Commercial Distribution

  • 00380740153953 ()
01R1821

  • Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay
Alinity i HAVAb IgG Reagent Kit 200 Tests
Abbott GmbH
08P2721
In Commercial Distribution

  • 00380740131371 ()
08P2721

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Alinity i Free T3 Reagent Kit 1200 Tests
ABBOTT IRELAND
07P6930
In Commercial Distribution

  • 00380740131111 ()
07P6930

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Alinity i Total T4 Reagent Kit 1200 Tests
ABBOTT IRELAND
07P9530
In Commercial Distribution

  • 00380740131524 ()
07P9530

  • Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay
Alinity i Total T4 Reagent Kit 200 Tests
ABBOTT IRELAND
07P9520
In Commercial Distribution

  • 00380740131517 ()
07P9520

  • Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay
Alinity i CA 15-3 Reagent Kit 1000 Tests
Abbott GmbH
08P5130
In Commercial Distribution

  • 00380740131449 ()
08P5130

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
Alinity i CA 15-3 Reagent Kit 200 Tests
Abbott GmbH
08P5120
In Commercial Distribution

  • 00380740131432 ()
08P5120

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
Alinity i Free T3 Reagent Kit 200 Tests
ABBOTT IRELAND
07P6920
In Commercial Distribution

  • 00380740131104 ()
07P6920

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Zinc oxide eugenol impression paste, Type I heavy-bodied
WATER PIK, INC.
012200-000
In Commercial Distribution

  • D686122003 ()

  • Weight: 80 Gram
  • Weight: 145 Gram
012200-000

  • Dental articulation paste/solution
Xpress 2 Dual Lead MIS Instrument Set I
Xtant Medical Holdings, Inc.
X073-0037
In Commercial Distribution

  • M697X07300370 ()
  • M697X07300371 ()


  • General internal orthopaedic fixation system implantation kit
HVT 2.0 Unit (Unpopulated, Nellcor I/O Board)
VAPOTHERM, INC.
HVT 2.0N-UNIT
In Commercial Distribution

  • 00841737103882 ()


  • Electrical mains power cable
  • Respiratory oxygen sensor
  • Professional high-flow respiratory unit, humidifying, manual
HVT 2.0 Unit (Unpopulated, Masimo I/O Board)
VAPOTHERM, INC.
HVT 2.0-UNIT
In Commercial Distribution

  • 00841737103875 ()


  • Electrical mains power cable
  • Respiratory oxygen sensor
  • Professional high-flow respiratory unit, humidifying, manual
Eyeglass Frame,"I Heart You,Tortoise/Blue,49"
ENCORE VISION, INC.
I Heart You
In Commercial Distribution

  • 00812056032825 ()


  • Prescription spectacles
HSV1 Herpes Simplex Virus Type I, ASR, 10mL
Slmp, LLC
ASR HSV1 Herpes Simplex Virus Type I Antibody (10mL)
In Commercial Distribution

  • 00810170552212 ()
RP87-10

  • Herpes simplex virus 1 (HSV1) antigen IVD, antibody
Double I/A Cannula 21g/19g, open end
Psi/Eye-Ko, Inc.
3002
In Commercial Distribution

  • 00840516120195 ()
  • 00840516116273 ()
  • 00840516124063 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Double I/A Cannula 21g/21g, open end
Psi/Eye-Ko, Inc.
3001
In Commercial Distribution

  • 00840516120188 ()
  • 00840516116266 ()
  • 00840516124056 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
"J" Shaped Double I/A Cannula 23g/25g
Psi/Eye-Ko, Inc.
3000J
In Commercial Distribution

  • 00840516120171 ()
  • 00840516116259 ()
  • 00840516124049 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Double I/A Cannula 21g/21g, side port
Psi/Eye-Ko, Inc.
3000
In Commercial Distribution

  • 00840516120164 ()
  • 00840516116242 ()
  • 00840516124032 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Double I/A Cannula 21g/19g, open end
Psi/Eye-Ko, Inc.
3002
In Commercial Distribution

  • 00840516104904 ()
  • 00840516108827 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Double I/A Cannula 21g/21g, open end
Psi/Eye-Ko, Inc.
3001
In Commercial Distribution

  • 00840516104898 ()
  • 00840516108810 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
"J" Shaped Double I/A Cannula 23g/25g
Psi/Eye-Ko, Inc.
3000J
In Commercial Distribution

  • 00840516104881 ()
  • 00840516108803 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Double I/A Cannula 21g/21g, side port
Psi/Eye-Ko, Inc.
3000
In Commercial Distribution

  • 00840516104874 ()
  • 00840516108797 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
MAX PRINT ORTHODONTIC ALGINATE TYPE I 21 G
MDC DENTAL
Max Print Orthodontic
In Commercial Distribution

  • 07506338321754 ()


  • Alginate dental impression material
MAX PRINT ALL PURPOSE TYPE I SAMPLE 21GR
MDC DENTAL
Max print
In Commercial Distribution

  • 07506338315104 ()


  • Alginate dental impression material
MAX PRINT CYAN ALGINATE TYPE I SAMPLE 21GR
MDC DENTAL
Max Print Cyan
In Commercial Distribution

  • 07506338315067 ()


  • Alginate dental impression material
MIMIC ALL PURPOSE ALGINATE TYPE I 1 LB
MDC DENTAL
MIMIC
In Commercial Distribution

  • 07506338313261 ()


  • Alginate dental impression material
MAX PRINT CYAN ALGINATE TYPE I 21 GR
MDC DENTAL
Max Print Cyan
In Commercial Distribution

  • 07506338303521 ()


  • Alginate dental impression material
CS 3700 3D I/O SCANNER CARBON GREY
CARESTREAM DENTAL LLC
CS 3700 3D I/O SCANNER CARBON GREY
In Commercial Distribution

  • 60192155942662 ()
5942669

  • Dental milling system, CAD/CAM, chairside
CS 3600 I/O SCANNER W/CS SCANFLOW
CARESTREAM DENTAL LLC
CS 3600
In Commercial Distribution

  • 60192155942341 ()

  • Weight: 1.8 Kilogram
  • Weight: 5 Kilogram
5942347

  • Dental milling system, CAD/CAM, chairside
CS 3700 3D I/O SCANNER ARCTIC WHITE
CARESTREAM DENTAL LLC
CS 3700
In Commercial Distribution

  • 60192155941306 ()
5941307

  • Dental milling system, CAD/CAM, chairside
SIZE C COLLIMAT. FOR I/O XRAY UNITS
CARESTREAM DENTAL LLC
CG799
Not in Commercial Distribution

  • 60192155154256 ()
5154257

  • Stationary intraoral dental x-ray system, digital
SIZE B COLLIMAT. FOR I/O XRAY UNITS
CARESTREAM DENTAL LLC
CG798
Not in Commercial Distribution

  • 60192155154249 ()
5154240

  • Stationary intraoral dental x-ray system, digital
SIZE C COLLIMAT. FOR I/O XRAY UNITS
CARESTREAM HEALTH, INC.
SIZE C COLLIMAT. FOR I/O XRAY UNITS
In Commercial Distribution

  • 60889975154251 ()
5154257

  • Stationary intraoral dental x-ray system, digital
SIZE B COLLIMAT. FOR I/O XRAY UNITS
CARESTREAM HEALTH, INC.
SIZE B COLLIMAT. FOR I/O XRAY UNITS
In Commercial Distribution

  • 60889975154244 ()
5154240

  • Stationary intraoral dental x-ray system, digital
SIZE A COLLIMAT. FOR I/O XRAY UNITS
CARESTREAM HEALTH, INC.
CG797
In Commercial Distribution

  • 60889975154237 ()
5154232

  • Stationary intraoral dental x-ray system, digital
I&D PACK FMOL LADY OF THE LAKE
MEDLINE INDUSTRIES, INC.
DYNJ89576
In Commercial Distribution

  • 40198459278533 ()
  • 10198459278532 ()
DYNJ89576

  • General surgical procedure kit, non-medicated, single-use
Goat antiserum to Human C-3b Inactivator (factor I)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761210 ()
121002

  • Complement reagent IVD
TRINIA EP 40 x 19 x 15mm (I)
BICON, LLC
260-616-115
In Commercial Distribution

  • 00813110029584 ()
260-616-115

  • Dental implant suprastructure, permanent, preformed
TRACOE phon assist I with Oxygen Supply Port
Tracoe medical GmbH
REF 650-TO-5
In Commercial Distribution

  • 04035324019151 ()
  • 05701780328418 ()

  • Connector Compatibility Fits on 15 mm connector
REF 650-TO-5

  • Tracheostomy tube speech valve
TRACOE phon assist I with Oxygen Supply Port
Tracoe medical GmbH
REF 650-TO
In Commercial Distribution

  • 04035324012930 ()

  • Connector Compatibility Fits on 15 mm connector
REF 650-TO

  • Tracheostomy tube speech valve
TRACOE phon assist I with Oxygen Supply Port
Tracoe medical GmbH
REF 650-SO
Not in Commercial Distribution

  • 04035324012923 ()

  • Fits to 22 mm adapter


  • Tracheostomy tube speech valve
LYFO DISK™ I. orientalis ATCC 6258™
MICROBIOLOGICS INC.
0227L
In Commercial Distribution

  • 10845357003642 ()
0227L

  • Multiple bacteria species culture isolate identification control IVD, kit
I/A Handpiece Handle, Titanium for SS Tips
Avalign Technologies, Inc.
92-IA31
In Commercial Distribution

  • 00190776375621 ()


  • Ophthalmic surgical instrument handle, manual
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