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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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IMMCO DIAGNOSTICS - 00845714003578

Primate Esophagus (Distal) Slide
IMMCO DIAGNOSTICS, INC.
2155-1
In Commercial Distribution

  • 00845714003578 ()

  • 6 wells
2155-1

  • General specimen microscopy slide IVD, single-use

IMMCO DIAGNOSTICS - 00845714001871

Celiac tTG IgG ELISA
IMMCO DIAGNOSTICS, INC.
5144G
In Commercial Distribution

  • 00845714001871 ()

  • 96 Determinations
5144G

  • Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)

IMMCO DIAGNOSTICS - 00845714001864

Celiac tTG lgA ELISA
IMMCO DIAGNOSTICS, INC.
5144A
In Commercial Distribution

  • 00845714001864 ()

  • 96 Determinations
5144A

  • Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)

IMMCO DIAGNOSTICS - 00845714001833

ACA IgM ELISA
IMMCO DIAGNOSTICS, INC.
5118M
Not in Commercial Distribution

  • 00845714001833 ()

  • 96 DETERMINATIONS
5118M

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

IMMCO DIAGNOSTICS - 00845714001826

ACA IgG ELISA
IMMCO DIAGNOSTICS, INC.
5118G
Not in Commercial Distribution

  • 00845714001826 ()

  • 96 determinations
5118G

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)

IMMCO DIAGNOSTICS - 00845714001178

Anti-Endomysial Antibody (EMA) IFA Kit
IMMCO DIAGNOSTICS, INC.
1114G-PDE
In Commercial Distribution

  • 00845714001178 ()

  • 48 DETERMINATIONS
1114G-PDE

  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

IMMCO DIAGNOSTICS - 00845714001147

Anti-Endomysial Antibody (EMA) IFA Kit
IMMCO DIAGNOSTICS, INC.
1114A-PDEX
In Commercial Distribution

  • 00845714001147 ()

  • 48 DETERMINATIONS
1114A-PDEX

  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

IMMCO DIAGNOSTICS - 00845714001130

Anti-Endomysial Antibody (EMA) IFA Kit
IMMCO DIAGNOSTICS, INC.
1114A-PDE-250X
In Commercial Distribution

  • 00845714001130 ()

  • 250 DETERMINATIONS
1114A-PDE-250X

  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

IMMCO DIAGNOSTICS - 00845714001123

Anti-Endomysial Antibody (EMA) IFA Kit
IMMCO DIAGNOSTICS, INC.
1114A-PDE-250
In Commercial Distribution

  • 00845714001123 ()

  • 250 DETERMINATIONS
1114A-PDE-250

  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

IMMCO DIAGNOSTICS - 00845714000768

Anti-Endomysial Antibody (EMA) IFA Kit
IMMCO DIAGNOSTICS, INC.
1114A-PDE
In Commercial Distribution

  • 00845714000768 ()

  • 48 DETERMINATIONS
1114A-PDE

  • Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay

ANAEROJAR (FULL ASSEMBLY) - 05032384027804

No Description
OXOID LIMITED
AG0025A
In Commercial Distribution

  • 05032384027804 ()


  • Atmospheric generation kit IVD

22mm Compact breathing system - 05030267161744

22mm Compact breathing system with 3L bag, monitoring line, HMEF, and Clearlite facemask >3 m
Intersurgical Incorporated
2158012
In Commercial Distribution

  • 05030267161751 ()
  • 05030267161744 ()


  • Anaesthesia breathing circuit, single-use

30MM UNIFLOW BS WITH 3L BAG LUER ELBOW MONITORING LINE ANAES FACE MASK AND HMEF - 05030267161614

30MM UNIFLOW BREATHING SYSTEM WITH 3L BAG, LUER ELBOW, MONITORING LINE, ANAESTHETIC FACE MASK AND HMEF 1.6M
Intersurgical Incorporated
2900077
In Commercial Distribution

  • 05030267161621 ()
  • 05030267161614 ()


  • Anaesthesia breathing circuit, single-use

22mm Compact breathing system - 05030267161539

22mm Compact breathing system with 3L bag, elbow, monitoring line, anesthetic face mask and HMEF >3m
Intersurgical Incorporated
2158019
In Commercial Distribution

  • 05030267161546 ()
  • 05030267161539 ()


  • Anaesthesia breathing circuit, single-use

2MM COMPACT BS WITH 3L BAG LUER ELBOW MONITORING LINE ANAES FACE MASK AND HMEF - 05030267160280

2MM COMPACT BREATHING SYSTEM WITH 3L BAG, LUER ELBOW, MONITORING LINE, ANAESTHETIC FACE MASK AND HMEF 3.0M
Intersurgical Incorporated
2158009
In Commercial Distribution

  • 05030267160297 ()
  • 05030267160280 ()


  • Anaesthesia breathing circuit, single-use

30MM UNIFLOW COAXIAL BS WITH 3L BAG INTEGRAL MONITORING LINE ANAES MASK AND HMEF - 05030267160266

30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH 3L BAG, INTEGRAL MONITORING LINE, ANAESTHETIC FACE MASK AND HMEF 1.6M
Intersurgical Incorporated
2902023
In Commercial Distribution

  • 05030267160273 ()
  • 05030267160266 ()


  • Anaesthesia breathing circuit, single-use

22MM COMPACT BS WITH 3L BAG LUER ELBOW MONITORING LINE ANAES FACE MASK AND HMEF - 05030267160228

22MM COMPACT BREATHING SYSTEM WITH 3L BAG, LUER ELBOW, MONITORING LINE, ANAESTHETIC FACE MASK AND HMEF 3.0M
Intersurgical Incorporated
2158010
In Commercial Distribution

  • 05030267160235 ()
  • 05030267160228 ()


  • Anaesthesia breathing circuit, single-use

30MM UNIFLOW COAXIAL BS WITH LUER ELBOW INTEGRAL MONITORING LINE AND LIMB, 2M - 05030267158065

30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH LUER ELBOW, INTEGRAL MONITORING LINE, AND LIMB, 2M
Intersurgical Incorporated
2902022
In Commercial Distribution

  • 05030267158072 ()
  • 05030267158065 ()


  • Anaesthesia breathing circuit, single-use

CLINITEK Novus® Automated Urine Chemistry Analyzer - 00630414981147

The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu
Siemens Healthcare Diagnostics Inc.
10697937
In Commercial Distribution

  • 00630414981147 ()
10697937

  • Urine analyser IVD, laboratory

22MM FLEXTUBE BS WITH 3L BAG MONITORING LINE ANAES FACE MASK AND HMEF - 05030267160303

22MM FLEXTUBE BREATHING SYSTEM WITH 3L BAG, MONITORING LINE, ANAESTHETIC FACE MASK AND HMEF 1.6M
Intersurgical Incorporated
2010261
In Commercial Distribution

  • 05030267160310 ()
  • 05030267160303 ()


  • Anaesthesia breathing circuit, reusable

22MM FLEXTUBE BS WITH 3L BAG LUER ELBOW MONITORING LINE ANAES FACE MASK AND HMEF - 05030267160242

22MM FLEXTUBE BREATHING SYSTEM WITH 3L BAG, LUER ELBOW, MONITORING LINE, ANAESTHETIC FACE MASK AND HMEF 1.6M
Intersurgical Incorporated
2010235
In Commercial Distribution

  • 05030267160259 ()
  • 05030267160242 ()


  • Anaesthesia breathing circuit, single-use

CLINITEK Novus® Automated Urine Chemistry Analyzer - 00630414981130

The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu
Siemens Healthcare Diagnostics Inc.
10494134
In Commercial Distribution

  • 00630414981130 ()
10494134

  • Urine analyser IVD, laboratory

Aria safety barb threaded housing (metric) - 00850013242863

Spare parts/replacement parts - threaded housing metric Aria safety barb
CYPRESS ADAPTIVE, LLC
CA300-SBTHM
In Commercial Distribution

  • 00850013242863 ()
CA300-SBTM

  • External lower-limb prosthesis suspensory component, non-powered

Aria safety barb threaded housing (US) - 00850013242856

Spare parts/replacement parts - Aria safety barb
CYPRESS ADAPTIVE, LLC
CA300-SBTH
In Commercial Distribution

  • 00850013242856 ()
CA300-SBTH

  • External lower-limb prosthesis suspensory component, non-powered

Aria valve threaded housing (metric) - 00850013242788

Spare parts/replacement parts for valves metric Threaded Housing for use with either Aria Valve metric and Aria valve Plus metric
CYPRESS ADAPTIVE, LLC
CA200-THM
In Commercial Distribution

  • 00850013242788 ()
CA200-THM

  • External lower-limb prosthesis suspensory component, non-powered

Aria Valve threaded housing (US) - 00850013242771

Spare parts/replacement parts for valves: US Threaded Housing for use with either Aria Valve US and Aria valve Plus US
CYPRESS ADAPTIVE, LLC
CA200-TH
In Commercial Distribution

  • 00850013242771 ()
CA200-TH

  • External lower-limb prosthesis suspensory component, non-powered

Aria Safety Barb (metric) - 00850013242108

Aria Safety barb, metric thread, with 90 degree swivel barb fitting for installation in high vacuum prosthetic sockets.
CYPRESS ADAPTIVE, LLC
CA300-ASBM
Not in Commercial Distribution

  • 00850013242108 ()
CA300-ASBM

  • External lower-limb prosthesis suspensory component, non-powered

Aria safety barb (US) - 00850013242092

Aria Safety barb (US threads) for installation in high vacuum prosthetic sockets.
CYPRESS ADAPTIVE, LLC
CA300-ASB
Not in Commercial Distribution

  • 00850013242092 ()
CA300-ASB

  • External lower-limb prosthesis suspensory component, non-powered

Aria valve plus (metric) - 00850013242047

Aria valve (metric) auto expulsion suction valve for prosthetic sockets.
CYPRESS ADAPTIVE, LLC
CA200AVPM
In Commercial Distribution

  • 00850013242047 ()
CA200AVPM

  • External lower-limb prosthesis suspensory component, non-powered

Aria Valve Plus (US) - 00850013242030

Aria valve plus auto-expulsion valve for installation in lower-limb prosthesis sockets for suction suspension.
CYPRESS ADAPTIVE, LLC
CA200-AVP
In Commercial Distribution

  • 00850013242030 ()
CA200-AVP

  • External lower-limb prosthesis suspensory component, non-powered
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