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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BIC BAND MAX I
Rmo, Inc.
B00546
In Commercial Distribution

  • 00000008857972 ()
  • 00885797091734 ()


  • Orthodontic metal band
W&I ROBOT PACK
DEROYAL INDUSTRIES, INC.
89-7764
In Commercial Distribution

  • 50749756773985 ()
  • 00749756773980 ()


  • General surgical procedure kit, non-medicated, single-use
KNEE ARTHROSCOPY PACK I
Cardinal Health 200, LLC
SOP31KAMN2
In Commercial Distribution

  • 50197106012459 ()
  • 10197106012451 ()
SOP31KAMN2

  • Arthroscopic surgical procedure kit, medicated
LAP CHOLE I PACK
DEROYAL INDUSTRIES, INC.
89-8056
In Commercial Distribution

  • 50749756806164 ()
  • 00749756806169 ()


  • Laparoscopic surgical procedure kit, non-medicated, single-use
JOURNEY I SLAP HAMMER
Smith & Nephew, Inc.
E0017971-1
In Commercial Distribution

  • 00885556892831 ()
E0017971-1

  • Orthopaedic inorganic implant inserter/extractor, reusable
HFHS CRANIOTOMY PACK I
Cardinal Health 200, LLC
SNEW1CRH13
In Commercial Distribution

  • 50195594616609 ()
  • 10195594616601 ()
SNEW1CRH13

  • Craniotomy kit
I AND D TRAY
Cardinal Health 200, LLC
08-7523A
In Commercial Distribution

  • 50195594692993 ()
  • 10195594692995 ()
08-7523A

  • General surgical procedure kit, non-medicated, single-use
VASCULAR CARE PACK I
Cardinal Health 200, LLC
SBA13LOEM1
In Commercial Distribution

  • 50197106243051 ()
  • 10197106243053 ()
SBA13LOEM1

  • Tracheostomy care kit, single-use
CATH LAB I PACK
Cardinal Health 200, LLC
SAN41CLTV2
In Commercial Distribution

  • 50197106255917 ()
  • 10197106255919 ()
SAN41CLTV2

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
CHEST TUBE PACK I
Cardinal Health 200, LLC
SCVDHCTPCB
In Commercial Distribution

  • 50195594868152 ()
  • 10195594868154 ()
SCVDHCTPCB

  • Cardiothoracic surgical procedure kit, medicated, single-use
HFHS CRANIOTOMY PACK I
Cardinal Health 200, LLC
SNEW1CRH16
In Commercial Distribution

  • 50195594869128 ()
  • 10195594869120 ()
SNEW1CRH16

  • Craniotomy kit
Threaded I/A Adapter
Diamatrix
IA-100
In Commercial Distribution

  • 00813059015228 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
KIT, I AND D
Cardinal Health 200, LLC
PGMHIDB16
In Commercial Distribution

  • 50197106876631 ()
  • 10197106876633 ()
PGMHIDB16

  • General surgical procedure kit, medicated
KNEE ARTHROSCOPY PACK I
Cardinal Health 200, LLC
SOP31KAMN5
In Commercial Distribution

  • 50197106221196 ()
  • 10197106221198 ()
SOP31KAMN5

  • Arthroscopic surgical procedure kit, medicated
KIT, I AND D
Cardinal Health 200, LLC
PGMHIDBH6
In Commercial Distribution

  • 50195594402691 ()
  • 10195594402693 ()
PGMHIDBH6

  • General surgical procedure kit, medicated
I R KYPHOPLASTY PK
Cardinal Health 200, LLC
SANCGKPNL2
In Commercial Distribution

  • 50195594410375 ()
  • 10195594410377 ()
SANCGKPNL2

  • Orthopaedic surgical procedure kit, medicated
KIT, I AND D
Cardinal Health 200, LLC
PGMHIDBH5
In Commercial Distribution

  • 50195594306739 ()
  • 10195594306731 ()
PGMHIDBH5

  • General surgical procedure kit, medicated
HFHS CRANIOTOMY PACK I
Cardinal Health 200, LLC
SNEW1CRH12
In Commercial Distribution

  • 50195594505309 ()
  • 10195594505301 ()
SNEW1CRH12

  • Craniotomy kit
CATH LAB I PACK
Cardinal Health 200, LLC
SAN41CLTVA
In Commercial Distribution

  • 50195594425690 ()
  • 10195594425692 ()
SAN41CLTVA

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

  • 50885425912719 ()
  • 00885425912714 ()
SNEHFLMRWA

  • Neurosurgical procedure kit, non-medicated, single-use
KIT, I AND D
Cardinal Health 200, LLC
PGMHIDBH7
In Commercial Distribution

  • 50195594533234 ()
  • 10195594533236 ()
PGMHIDBH7

  • General surgical procedure kit, medicated
Oxygen PulseDose Conserver - I
DEVILBISS HEALTHCARE LLC
PD1000I
Not in Commercial Distribution

  • 00885304012252 ()
PD1000I

  • Non-fixed medical gas cylinder regulator
LAP CHOLE PACK I
Cardinal Health 200, LLC
SBA69LAAS6
In Commercial Distribution

  • 50195594682406 ()
  • 10195594682408 ()
SBA69LAAS6

  • Laparoscopic surgical procedure kit, medicated
I Pack Injection Kit
DEROYAL INDUSTRIES, INC.
19002
In Commercial Distribution

  • 50749756886876 ()
  • 00749756886871 ()


  • General surgical procedure kit, non-medicated, single-use
NMH I R PORT
Cardinal Health 200, LLC
SAN31IRNM5
In Commercial Distribution

  • 50195594370792 ()
  • 10195594370794 ()
SAN31IRNM5

  • Angiography kit
I R KYPHOPLASTY PK
Cardinal Health 200, LLC
SANCGKPNLA
In Commercial Distribution

  • 50195594156037 ()
  • 10195594156039 ()
SANCGKPNLA

  • Orthopaedic surgical procedure kit, medicated
IV START TRAY I
Cardinal Health 200, LLC
01-5799A
In Commercial Distribution

  • 50195594381965 ()
  • 10195594381967 ()
01-5799A

  • General surgical procedure kit, medicated
HFHS CRANIOTOMY PACK I
Cardinal Health 200, LLC
SNEW1CRH11
In Commercial Distribution

  • 50195594373434 ()
  • 10195594373436 ()
SNEW1CRH11

  • Craniotomy kit
I R KYPHOPLASTY PK
Cardinal Health 200, LLC
SANCGKPNL1
In Commercial Distribution

  • 50195594348715 ()
  • 10195594348717 ()
SANCGKPNL1

  • Orthopaedic surgical procedure kit, medicated
KIT, I AND D
Cardinal Health 200, LLC
PGMHIDBHJ
In Commercial Distribution

  • 50195594439840 ()
  • 10195594439842 ()
PGMHIDBHJ

  • General surgical procedure kit, medicated
I AND D TRAY
Cardinal Health 200, LLC
08-8365B
In Commercial Distribution

  • 50195594451002 ()
  • 10195594451004 ()
08-8365B

  • General surgical procedure kit, medicated
KIT, I AND D
Cardinal Health 200, LLC
PGMHIDBHM
In Commercial Distribution

  • 50198956130058 ()
  • 10198956130050 ()
PGMHIDBHM

  • General surgical procedure kit, medicated
Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only
BIO-RAD LABORATORIES, INC.
SW4.1_1
In Commercial Distribution

  • 00847865012997 ()

  • 1 Each
6652165B

  • Phospholipid antibody IVD, kit, multiplex
Manual & CDs, BioPlex 2200 APLS IgG IFU, SW4_v1, US Only
BIO-RAD LABORATORIES, INC.
SW4_1
In Commercial Distribution

  • 00847865012522 ()

  • 1 Each
6651965A

  • Phospholipid antibody IVD, kit, multiplex
APLS IgG, IgM and IgA Assay Protocol File CD, SW4_v1
BIO-RAD LABORATORIES, INC.
SW4_1
In Commercial Distribution

  • 00847865012508 ()

  • 1 Each
6651975A

  • Phospholipid antibody IVD, kit, multiplex
Manual & CDs, APLS IgA IFU, SW4_v1, US Only
BIO-RAD LABORATORIES, INC.
SW4_1
In Commercial Distribution

  • 00847865002998 ()

  • 1 Each
6652165A

  • Phospholipid antibody IVD, kit, multiplex
APLS IgA Reagent Pack
BIO-RAD LABORATORIES, INC.
6652150
In Commercial Distribution

  • 00847865000710 ()

  • 100 Tests
6652150

  • Phospholipid antibody IVD, kit, multiplex
APLS IgM Reagent Pack
BIO-RAD LABORATORIES, INC.
6652050
In Commercial Distribution

  • 00847865000666 ()

  • 100 Tests
6652050

  • Phospholipid antibody IVD, kit, multiplex
APLS IgG Reagent Pack
BIO-RAD LABORATORIES, INC.
6651950
In Commercial Distribution

  • 00847865000604 ()

  • 100 Number of Tests
6651950

  • Phospholipid antibody IVD, kit, multiplex
Manual & CDs, APLS IgM IFU, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1V1
In Commercial Distribution

  • 00847865012980 ()

  • 1 Each
6652065B

  • Phospholipid antibody IVD, kit, multiplex
APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only
BIO-RAD LABORATORIES, INC.
SW4.1V1
In Commercial Distribution

  • 00847865012973 ()

  • 1 Each
6651975B

  • Phospholipid antibody IVD, kit, multiplex
Manual & CDs, APLS IgG IFU, SW4.1_v1, US Only
BIO-RAD LABORATORIES, INC.
SW4.1V1
In Commercial Distribution

  • 00847865012966 ()

  • 1 Each
6651965B

  • Phospholipid antibody IVD, kit, multiplex
Manual & CDs, APLS IgM IFU, SW4_v1, US Only
BIO-RAD LABORATORIES, INC.
SW4_1
In Commercial Distribution

  • 00847865012515 ()

  • 1 Each
6652065A

  • Phospholipid antibody IVD, kit, multiplex
-100 ea. fecal extraction devices containing 2.8 mL of extraction buffer -100 ea. white caps
INOVA DIAGNOSTICS, INC.
504837
In Commercial Distribution

  • 08426950846833 ()


  • Calprotectin IVD, kit, chemiluminescent immunoassay
  • Multiple gastrointestinal disease marker IVD, kit, enzyme immunoassay (EIA)
Validate CM2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
402re
In Commercial Distribution

  • 00859110005647 ()

  • 2 tests
402re

  • C-reactive protein (CRP) IVD, control
  • Multiple cardiac marker IVD, control
Validate CM2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
402vt
In Commercial Distribution

  • 00859110005654 ()

  • 2 tests
402vt

  • C-reactive protein (CRP) IVD, control
  • Multiple cardiac marker IVD, control
Validate CM2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
402bc
In Commercial Distribution

  • 00859110005630 ()

  • 2 tests
402bc

  • C-reactive protein (CRP) IVD, control
  • Multiple cardiac marker IVD, control
Validate CM2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
402ab
In Commercial Distribution

  • 00859110005623 ()

  • 2 tests
402ab

  • C-reactive protein (CRP) IVD, control
  • Multiple cardiac marker IVD, control
Horz Ratchet Bar wJumbo I I Arm Mount Sys for Harring Blade
Automated Medical Products Corp.
Horz Ratchet Bar wJumbo I I Arm Mount Sys for Harring Blade
In Commercial Distribution

  • 00810118341199 ()
GIHJAM

  • Surgical retractor/retraction system blade, reusable
I/A BIMANUELL INSTRUMENTEN-SET; I/A BIMANUAL INSTRUMENT KIT; JEU D'INSTRUMENTS BIMANUELS
Oertli-Instrumente AG
VE654101
In Commercial Distribution

  • 07630003900958 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
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