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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GammaPro Angled Standard Probe used for wireless ionizing radiation detection.
Kubtec
K0021C01
In Commercial Distribution

  • B619GPROSTDANGPROBE0 ()


  • Mobile gamma camera system
Gamma P1 Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-P1 activity in serum or plasma. Gamma P1 Blood Group Substance is a standardized solution of avian P1 blood group substance in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
IMMUCOR, INC.
0007700
In Commercial Distribution

  • 10888234000846 ()
0007700

  • Immunoglobulin removal reagent IVD
Gamma Lewis Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-Lea and anti-Leb activity in serum or plasma. Gamma Lewis Blood Group Substance is a standardized solution of human Lea and Leb blood group substances in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
IMMUCOR, INC.
0007702
In Commercial Distribution

  • 10888234000853 ()
0007702

  • Immunoglobulin removal reagent IVD
Gait Belt- Plastic Buckle, Multi-Color, 60"x2"
DYNAREX CORPORATION
4354
In Commercial Distribution

  • 00616784435435 ()
  • 00616784435411 ()


  • Gait rehabilitation system harness
Gait Belt, Metal Buckle, Multi-color, 60"x2"
DYNAREX CORPORATION
4353
In Commercial Distribution

  • 00616784435336 ()
  • 00616784435312 ()


  • Gait rehabilitation system harness
Gait Belt- Metal Buckle, Natural Color, 60"x2"
DYNAREX CORPORATION
4352
In Commercial Distribution

  • 00616784435237 ()
  • 00616784435213 ()


  • Gait rehabilitation system harness
Gait Belt, Wipeable, Vinyl, Plastic Buckle, Red and Black
DYNAREX CORPORATION
4345
In Commercial Distribution

  • 00616784434537 ()
  • 00616784434513 ()


  • Gait rehabilitation system harness
Gait Belt, Antimicrobial, Metal Buckle, Blue and White
DYNAREX CORPORATION
4344
In Commercial Distribution

  • 00616784434438 ()
  • 00616784434414 ()


  • Gait rehabilitation system harness
No Description
ALIMED, INC.
7083
In Commercial Distribution

  • 00733657223897 ()
2970008349

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
70256
In Commercial Distribution

  • 00733657227666 ()
2970008129

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
70257
In Commercial Distribution

  • 00733657227673 ()
2970008130

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
77178
In Commercial Distribution

  • 00733657228823 ()
2970010129

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
77175
In Commercial Distribution

  • 00733657228793 ()
2970010127

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
710135
In Commercial Distribution

  • 00733657230635 ()
  • 00733657299281 ()
2970008478

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
710131
In Commercial Distribution

  • 00733657230598 ()
  • 00733657299267 ()
2970008476

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
710129
In Commercial Distribution

  • 00733657230574 ()
  • 00733657299250 ()
2970008475

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
710126
In Commercial Distribution

  • 00733657230543 ()
  • 00733657299236 ()
2970008473

  • Movement-resistance gait rehabilitation device
No Description
ALIMED, INC.
710128
In Commercial Distribution

  • 00733657230567 ()
  • 00733657299243 ()
2970008474

  • Movement-resistance gait rehabilitation device
Robotic-assisted gait trainer
Reha Technology AG
G-EO System
In Commercial Distribution

  • 07640174420018 ()


  • Treadmill/elliptical gait rehabilitation system
Robotic-assisted gait trainer
Reha Technology AG
G-EO
In Commercial Distribution

  • 07640174420032 ()


  • Treadmill/elliptical gait rehabilitation system
Super-BGMK FLK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
70-T225
In Commercial Distribution

  • 30014613338420 ()
70-T225

  • Cell culture line IVD
BGMK FLK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
53-T225
In Commercial Distribution

  • 30014613338413 ()
53-T225

  • Cell culture line IVD
RHMK FLK 225
DIAGNOSTIC HYBRIDS, INC.
49-T225DH
In Commercial Distribution

  • 30014613338307 ()
49-T225DH

  • Cell culture line IVD
MDCK FLASK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
83-T225DH
In Commercial Distribution

  • 30014613338260 ()
83-T225DH

  • Cell culture line IVD
HEP-2 W96/96
DIAGNOSTIC HYBRIDS, INC.
57-9696
In Commercial Distribution

  • 30014613333364 ()
57-9696

  • Cell culture line IVD
HEP-2 MWP 4848
DIAGNOSTIC HYBRIDS, INC.
57-4848
In Commercial Distribution

  • 30014613333357 ()
57-4848

  • Cell culture line IVD
HEP2 PLATE W48/24F
DIAGNOSTIC HYBRIDS, INC.
57-4824
In Commercial Distribution

  • 30014613333340 ()
57-4824

  • Cell culture line IVD
HEP2 PLATE W24/24F
DIAGNOSTIC HYBRIDS, INC.
57-2424
In Commercial Distribution

  • 30014613333333 ()
57-2424

  • Cell culture line IVD
HEP2 PLATE W24/06F
DIAGNOSTIC HYBRIDS, INC.
57-2406
In Commercial Distribution

  • 30014613333326 ()
57-2406

  • Cell culture line IVD
HEP2 TUBE
DIAGNOSTIC HYBRIDS, INC.
57-0600
In Commercial Distribution

  • 30014613333319 ()
57-0600

  • Cell culture line IVD
HEP2 SV/CS
DIAGNOSTIC HYBRIDS, INC.
57-0102
In Commercial Distribution

  • 30014613333302 ()
57-0102

  • Cell culture line IVD
HEP-2 FROZEN SUSP. 50 MER
DIAGNOSTIC HYBRIDS, INC.
57-00050
In Commercial Distribution

  • 30014613333296 ()
57-00050

  • Cell culture line IVD
A549 FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
56-T150
In Commercial Distribution

  • 30014613333289 ()
56-T150

  • Cell culture line IVD
A549 FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
56-T075
In Commercial Distribution

  • 30014613333272 ()
56-T075

  • Cell culture line IVD
A549 FLASK 25 SQ CM
DIAGNOSTIC HYBRIDS, INC.
56-T025
In Commercial Distribution

  • 30014613333265 ()
56-T025

  • Cell culture line IVD
A549 PLATE W96/96F
DIAGNOSTIC HYBRIDS, INC.
56-9696
In Commercial Distribution

  • 30014613333258 ()
56-9696

  • Cell culture line IVD
A549 PLATE W96/60F
DIAGNOSTIC HYBRIDS, INC.
56-9660
In Commercial Distribution

  • 30014613333241 ()
56-9660

  • Cell culture line IVD
A549 CELLS MWP W96/32 CUST
DIAGNOSTIC HYBRIDS, INC.
56-9632C
In Commercial Distribution

  • 30014613333234 ()
56-9632C

  • Cell culture line IVD
A549 CELLS MWP W96/24 CUST
DIAGNOSTIC HYBRIDS, INC.
56-9624C
In Commercial Distribution

  • 30014613333227 ()
56-9624C

  • Cell culture line IVD
A549 PLATE W48/48F
DIAGNOSTIC HYBRIDS, INC.
56-4848
In Commercial Distribution

  • 30014613333210 ()
56-4848

  • Cell culture line IVD
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