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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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Cytocell Aquarius - 05055844901605

P53 (TP53) Deletion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH017
In Commercial Distribution

  • 05055844901605 ()
USA-LPH017

  • Myelodysplastic syndrome (MDS) IVD, probe
  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe

Cytocell Aquarius - 05055844901599

MLL (KMT2A) Breakapart FISH Probe Kit
CYTOCELL LIMITED
USA-LPH013
In Commercial Distribution

  • 05055844901599 ()
USA-LPH013

  • Myelodysplastic syndrome (MDS) IVD, probe
  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe

Cytocell Aquarius - 05055844901582

EVI1 (MECOM) Breakapart FISH Probe Kit
CYTOCELL LIMITED
USA-LPH036
In Commercial Distribution

  • 05055844901582 ()
USA-LPH036

  • Myelodysplastic syndrome (MDS) IVD, probe
  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe

Cytocell Aquarius - 05055844901568

Del(7q) Deletion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH025
In Commercial Distribution

  • 05055844901568 ()
USA-LPH025

  • Myelodysplastic syndrome (MDS) IVD, probe
  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe

Cytocell Aquarius - 05055844901551

Del(5q) Deletion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH024
In Commercial Distribution

  • 05055844901551 ()
USA-LPH024

  • Myelodysplastic syndrome (MDS) IVD, probe
  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe

CytoCell - 05055844923904

EVI1 (MECOM) Breakapart FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH036
In Commercial Distribution



  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
  • Myelodysplastic syndrome (MDS) IVD, probe

CytoCell - 05055844923881

Del(7q) Deletion FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH025
In Commercial Distribution



  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
  • Myelodysplastic syndrome (MDS) IVD, probe

CytoCell - 05055844923874

Del(5q) Deletion FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH024
In Commercial Distribution



  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
  • Myelodysplastic syndrome (MDS) IVD, probe

CytoCell - 05055844923843

P53 (TP53) Deletion FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH017
In Commercial Distribution



  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
  • Myelodysplastic syndrome (MDS) IVD, probe

CytoCell - 05055844923836

MLL (KMT2A) Breakapart FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH013
In Commercial Distribution



  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
  • Myelodysplastic syndrome (MDS) IVD, probe

NA - 05060191070850

Applicator 20 x 20
ELEKTA LIMITED
1525331
In Commercial Distribution

  • 05060191070850 ()


  • Linear accelerator system

Ease Cushion - 00860002071206

20" x 20" cushion
Ease Seating Systems
20x20 cushion
Not in Commercial Distribution

  • 00860002071206 ()


  • Alternating-pressure chair cushion, reusable

Arthrex® - 00888867041509

2-0 FIBERSTICK, 2-0 FIBERWIRE
ARTHREX, INC.
AR-7222
In Commercial Distribution

  • 00888867041509 ()
  • M150AR72222 ()
  • 10888867041506 ()
AR-7222

  • Polyolefin/fluoropolymer suture, multifilament

Arthrex® - 00888867280939

2-0 FIBERSTICK, 2-0 FIBERWIRE
ARTHREX, INC.
AR-7222-1
In Commercial Distribution

  • 00888867280939 ()
AR-7222-1

  • Polyolefin/fluoropolymer suture, multifilament

Z-Staple - 04057217003702

Z-Staple 20 / 20 mm
Z-Medical GmbH + Co. KG
C03 210
In Commercial Distribution

  • 04057217003702 ()


  • Orthopaedic bone staple, non-adjustable

MEDLINE - 10197344007752

360-360I,20/20,CMSQ12RA
MEDLINE INDUSTRIES, INC.
613360503
In Commercial Distribution

  • 20197344007759 ()
  • 10197344007752 ()
  • 30197344007756 ()
613360503

  • Angiography kit

Cryotec - 04589700010107

Kitazato Cryotec (10 pieces) (White)
REPROLIFE INC.
TEC110W
Not in Commercial Distribution

  • 04589700010107 ()
  • 45897000110012 ()
TEC110W

  • Tissue cryostorage straw

Cryotec - 04589700010084

Kitazato Cryotec (10 pieces) (Yellow)
REPROLIFE INC.
TEC110Y
Not in Commercial Distribution

  • 04589700010084 ()
  • 45897000108019 ()
TEC110Y

  • Tissue cryostorage straw

Cryotec - 04589700010060

Kitazato Cryotec (10 pieces) (Blue)
REPROLIFE INC.
TEC110B
Not in Commercial Distribution

  • 04589700010060 ()
  • 45897000106015 ()
TEC110B

  • Tissue cryostorage straw

Cryotec - 04589700010053

Cryotec (10 pieces) (White)
REPROLIFE INC.
TEC010W
In Commercial Distribution

  • 04589700010053 ()
  • 00045897000105 ()
TEC010W

  • Tissue cryostorage straw

Cryotec - 04589700010046

Cryotec (10 pieces) (Green)
REPROLIFE INC.
TEC010G
In Commercial Distribution

  • 04589700010046 ()
  • 00045897000104 ()
TEC010G

  • Tissue cryostorage straw

Cryotec - 04589700010039

Cryotec (10 pieces) (Yellow)
REPROLIFE INC.
TEC010Y
In Commercial Distribution

  • 04589700010039 ()
  • 00045897000103 ()
TEC010Y

  • Tissue cryostorage straw

Cryotec - 04589700010022

Cryotec (10 pieces) (Red)
REPROLIFE INC.
TEC010R
In Commercial Distribution

  • 04589700010022 ()
  • 00045897000102 ()
TEC010R

  • Tissue cryostorage straw

Cryotec - 04589700010015

Cryotec (10 pieces) (Blue)
REPROLIFE INC.
TEC010B
In Commercial Distribution

  • 04589700010015 ()
  • 00045897000101 ()
TEC010B

  • Tissue cryostorage straw

Cryotec - 04589700010206

Kitazato Cryotec (4 pieces) (White)
REPROLIFE INC.
TEC104W
Not in Commercial Distribution

  • 04589700010206 ()
  • 45897000120011 ()
TEC104W

  • Tissue cryostorage straw

Cryotec - 04589700010190

Kitazato Cryotec (4 pieces) (Green)
REPROLIFE INC.
TEC104G
Not in Commercial Distribution

  • 04589700010190 ()
  • 45897000119015 ()
TEC104G

  • Tissue cryostorage straw

Cryotec - 04589700010183

Kitazato Cryotec (4 pieces) (Yellow)
REPROLIFE INC.
TEC104Y
Not in Commercial Distribution

  • 04589700010183 ()
  • 45897000118018 ()
TEC104Y

  • Tissue cryostorage straw

Cryotec - 04589700010176

Kitazato Cryotec (4 pieces) (Red)
REPROLIFE INC.
TEC104R
Not in Commercial Distribution

  • 04589700010176 ()
  • 45897000117011 ()
TEC104R

  • Tissue cryostorage straw

Cryotec - 04589700010169

Kitazato Cryotec (4 pieces) (Blue)
REPROLIFE INC.
TEC104B
Not in Commercial Distribution

  • 04589700010169 ()
  • 45897000116014 ()
TEC104B

  • Tissue cryostorage straw

Cryotec - 04589700010152

Cryotec (4 pieces) (White)
REPROLIFE INC.
TEC004W
In Commercial Distribution

  • 04589700010152 ()
  • 00045897000115 ()
TEC004W

  • Tissue cryostorage straw

Cryotec - 04589700010145

Cryotec (4 pieces) (Green)
REPROLIFE INC.
TEC004G
In Commercial Distribution

  • 04589700010145 ()
  • 00045897000114 ()
TEC004G

  • Tissue cryostorage straw

Cryotec - 04589700010138

Cryotec (4 pieces) (Yellow)
REPROLIFE INC.
TEC004Y
In Commercial Distribution

  • 04589700010138 ()
  • 00045897000113 ()
TEC004Y

  • Tissue cryostorage straw

Cryotec - 04589700010121

Cryotec (4 pieces) (Red)
REPROLIFE INC.
TEC004R
In Commercial Distribution

  • 04589700010121 ()
  • 00045897000112 ()
TEC004R

  • Tissue cryostorage straw

Cryotec - 04589700010114

Cryotec (4 pieces) (Blue)
REPROLIFE INC.
TEC004B
In Commercial Distribution

  • 04589700010114 ()
  • 00045897000111 ()
TEC004B

  • Tissue cryostorage straw

Cryotec - 04589700010091

Kitazato Cryotec (10 pieces) (Green)
REPROLIFE INC.
TEC110G
Not in Commercial Distribution

  • 04589700010091 ()
  • 45897000109016 ()
TEC110G

  • Tissue cryostorage straw

Cryotec - 04589700010077

Kitazato Cryotec (10 pieces) (Red)
REPROLIFE INC.
TEC110R
Not in Commercial Distribution

  • 04589700010077 ()
  • 45897000107012 ()
TEC110R

  • Tissue cryostorage straw

IMMULITE® 2000 Systems aBC Calibration Verification Material Anti-HBC - 00630414978017

Anti-HBc IgM CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373676
In Commercial Distribution

  • 00630414978017 ()
L2MCCVM

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

X-Series - 00850015266614

Single-Use Strip Sensor Kit
ADVANCED BRAIN MONITORING, INC.
XS30-4301
In Commercial Distribution

  • 00850015266614 ()


  • Patient monitoring system module, electroencephalographic

X-Series - 00850015266935

Universal Strip Sensor Kit
ADVANCED BRAIN MONITORING, INC.
XS30-4302
In Commercial Distribution

  • 00850015266935 ()


  • Patient monitoring system module, electroencephalographic

X-Series - 00850015266423

X-Small 10-20 Single-Use Strip Kit (Qty 2)
ADVANCED BRAIN MONITORING, INC.
XS30-4210.2
In Commercial Distribution

  • 00850015266423 ()


  • Patient monitoring system module, electroencephalographic

X-Series - 00850015266331

Medium 10-20 Single-Use Strip Kit (Qty 5)
ADVANCED BRAIN MONITORING, INC.
XS30-4212.5
In Commercial Distribution

  • 00850015266331 ()


  • Patient monitoring system module, electroencephalographic

X-Series - 00850015266324

Small 10-20 Single-Use Strip Kit (Qty 5)
ADVANCED BRAIN MONITORING, INC.
XS30-4211.5
In Commercial Distribution

  • 00850015266324 ()


  • Patient monitoring system module, electroencephalographic

X-Series - 00850015266317

Medium 10-20 Single-Use Strip Kit
ADVANCED BRAIN MONITORING, INC.
XS30-4212
In Commercial Distribution

  • 00850015266317 ()


  • Patient monitoring system module, electroencephalographic

X-Series - 00850015266300

Small 10-20 Single-Use Strip Kit
ADVANCED BRAIN MONITORING, INC.
XS30-4211
In Commercial Distribution

  • 00850015266300 ()


  • Patient monitoring system module, electroencephalographic

X-Series - 00851113007895

X24 Disposable Sensor Kit
ADVANCED BRAIN MONITORING, INC.
XS24-4321
In Commercial Distribution

  • 00851113007895 ()


  • Analytical scalp electrode, single-use

X-Series - 00851113007888

X10 Disposable Sensor Kit
ADVANCED BRAIN MONITORING, INC.
XS10-4321
In Commercial Distribution

  • 00851113007888 ()


  • Analytical scalp electrode, single-use

X-Series - 00851113007451

Synapse Cream Kit
ADVANCED BRAIN MONITORING, INC.
XS02-4351
In Commercial Distribution

  • 00851113007451 ()


  • Electrode conductive medium

BISICO Cem DC A3 - EBIB752401

Double-curing, fine-flowing micro-hybrid composite material for permanent attachment of crowns, bridges, inlays and endodontic posts made of carbon fibers and glass fibers. Used by a dentist.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
75240
In Commercial Distribution

  • EBIB752401 ()
75240

  • Dental composite resin

BISICO Repo-Core DC A3 25ml - EBIB752201

Double-curing, free-flowing, radiopaque composite material that is used to build the core and cement roots. Used by a dentist.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
75220
In Commercial Distribution

  • EBIB752201 ()
75220

  • Dental composite resin

BISICO Repo-Core DC A3 Mini - EBIB752001

Double-curing, free-flowing, radiopaque composite material that is used to build the core and cement roots. Used by a dentist.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
75200
In Commercial Distribution

  • EBIB752001 ()
75200

  • Dental composite resin
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