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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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Fresh Cells - 30014613331858

AGMK FROZEN SUSP.
DIAGNOSTIC HYBRIDS, INC.
46-00020
In Commercial Distribution

  • 30014613331858 ()
46-00020

  • Cell culture line IVD

Fresh Cells - 30014613331841

MRHF FLASK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
44-T225
In Commercial Distribution

  • 30014613331841 ()
44-T225

  • Cell culture line IVD

Fresh Cells - 30014613331834

MRHF FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
44-T150
In Commercial Distribution

  • 30014613331834 ()
44-T150

  • Cell culture line IVD

Fresh Cells - 30014613331827

MRHF FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
44-T075
In Commercial Distribution

  • 30014613331827 ()
44-T075

  • Cell culture line IVD

Fresh Cells - 30014613331810

MRHF FLASK 25 SQ CM
DIAGNOSTIC HYBRIDS, INC.
44-T025
In Commercial Distribution

  • 30014613331810 ()
44-T025

  • Cell culture line IVD

Fresh Cells - 30014613331803

MRHF PLATE W96 96F
DIAGNOSTIC HYBRIDS, INC.
44-9696
In Commercial Distribution

  • 30014613331803 ()
44-9696

  • Cell culture line IVD

Fresh Cells - 30014613331797

MRHF PLATE W96 (EOC)
DIAGNOSTIC HYBRIDS, INC.
44-9648C
In Commercial Distribution

  • 30014613331797 ()
44-9648C

  • Cell culture line IVD

Fresh Cells - 30014613331780

MRHF MW PLATE W96/12F
DIAGNOSTIC HYBRIDS, INC.
44-9612
In Commercial Distribution

  • 30014613331780 ()
44-9612

  • Cell culture line IVD

Fresh Cells - 30014613331773

MRHF PLATE W24/24F
DIAGNOSTIC HYBRIDS, INC.
44-2424
In Commercial Distribution

  • 30014613331773 ()
44-2424

  • Cell culture line IVD

Fresh Cells - 30014613331766

MRHF TUBE CULT
DIAGNOSTIC HYBRIDS, INC.
44-0600
In Commercial Distribution

  • 30014613331766 ()
44-0600

  • Cell culture line IVD

Fresh Cells - 30014613331759

MRHF SHELL VIAL W/CS
DIAGNOSTIC HYBRIDS, INC.
44-0102
In Commercial Distribution

  • 30014613331759 ()
44-0102

  • Cell culture line IVD

Fresh Cells - 30014613331742

MRHF FROZEN SUSP. 50 MER
DIAGNOSTIC HYBRIDS, INC.
44-00050
In Commercial Distribution

  • 30014613331742 ()
44-00050

  • Cell culture line IVD

Fresh Cells - 30014613331735

HEL FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
43-T150
In Commercial Distribution

  • 30014613331735 ()
43-T150

  • Cell culture line IVD

Fresh Cells - 30014613331728

HEL FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
43-T075
In Commercial Distribution

  • 30014613331728 ()
43-T075

  • Cell culture line IVD

Fresh Cells - 30014613331711

HEL TUBE
DIAGNOSTIC HYBRIDS, INC.
43-0600
In Commercial Distribution

  • 30014613331711 ()
43-0600

  • Cell culture line IVD

Fresh Cells - 30014613331704

NHFL 75 SQ CM LOW PASSAGE
DIAGNOSTIC HYBRIDS, INC.
42-T075C
In Commercial Distribution

  • 30014613331704 ()
42-T075C

  • Cell culture line IVD

Fresh Cells - 30014613331698

NHFL 75 SQ CM FLK
DIAGNOSTIC HYBRIDS, INC.
42-T075
In Commercial Distribution

  • 30014613331698 ()
42-T075

  • Cell culture line IVD

Fresh Cells - 30014613331445

RMK SV5/SV40 PLATE 24-WELL
DIAGNOSTIC HYBRIDS, INC.
18-309-24
In Commercial Distribution

  • 30014613331445 ()
18-309-24

  • Cell culture line IVD

Fresh Cells - 30014613331438

RMK SV5/SV40 FLK/75 CM2
DIAGNOSTIC HYBRIDS, INC.
16-309-75
In Commercial Distribution

  • 30014613331438 ()
16-309-75

  • Cell culture line IVD

Fresh Cells - 30014613331421

RMK SV5/SV40 FLK/150 CM2
DIAGNOSTIC HYBRIDS, INC.
16-309-150
In Commercial Distribution

  • 30014613331421 ()
16-309-150

  • Cell culture line IVD

Fresh Cells - 30014613331414

RMK FLKS/75 CM2
DIAGNOSTIC HYBRIDS, INC.
16-308-75
In Commercial Distribution

  • 30014613331414 ()
16-308-75

  • Cell culture line IVD

Fresh Cells - 30014613331407

RMK SV5/SV40 VIAL/SNAP CAP
DIAGNOSTIC HYBRIDS, INC.
15-309
In Commercial Distribution

  • 30014613331407 ()
15-309

  • Cell culture line IVD

Fresh Cells - 30014613331391

PMK VIAL/SNAP CAP
DIAGNOSTIC HYBRIDS, INC.
15-308
In Commercial Distribution

  • 30014613331391 ()
15-308

  • Cell culture line IVD

Fresh Cells - 30014613331384

RMK SV5/SV40 TUBE
DIAGNOSTIC HYBRIDS, INC.
14-309
In Commercial Distribution

  • 30014613331384 ()
14-309

  • Cell culture line IVD

Fresh Cells - 30014613331377

RMK TUBE
DIAGNOSTIC HYBRIDS, INC.
14-308
In Commercial Distribution

  • 30014613331377 ()
14-308

  • Cell culture line IVD

GAIT BELT DISP BLUE 54 IN METAL BUCKLE CS 100 - 00733657230567

No Description
ALIMED, INC.
710128
In Commercial Distribution

  • 00733657230567 ()
  • 00733657299243 ()
2970008474

  • Movement-resistance gait rehabilitation device

GAIT BELT DISP BLUE 54 IN METAL BUCKLE CS 36 - 00733657230543

No Description
ALIMED, INC.
710126
In Commercial Distribution

  • 00733657230543 ()
  • 00733657299236 ()
2970008473

  • Movement-resistance gait rehabilitation device

GAIT BELT DISP BLUE 54 IN PLASTIC BUCKLE CS 36 - 00733657230574

No Description
ALIMED, INC.
710129
In Commercial Distribution

  • 00733657230574 ()
  • 00733657299250 ()
2970008475

  • Movement-resistance gait rehabilitation device

GAIT BELT DISP BLUE 54 IN PLASTIC BUCKLECS 100 - 00733657230598

No Description
ALIMED, INC.
710131
In Commercial Distribution

  • 00733657230598 ()
  • 00733657299267 ()
2970008476

  • Movement-resistance gait rehabilitation device

GAIT BELT DISP BLUE 70 IN PLASTIC BUCKLE CS 36 - 00733657230635

No Description
ALIMED, INC.
710135
In Commercial Distribution

  • 00733657230635 ()
  • 00733657299281 ()
2970008478

  • Movement-resistance gait rehabilitation device

GAIT BELT RED/WHIT/BLUE 54 INCH METAL BUCKLE - 00733657228793

No Description
ALIMED, INC.
77175
In Commercial Distribution

  • 00733657228793 ()
2970010127

  • Movement-resistance gait rehabilitation device

GAIT BELT RED/WHIT/BLUE 70 INCH METAL BUCKLE - 00733657228823

No Description
ALIMED, INC.
77178
In Commercial Distribution

  • 00733657228823 ()
2970010129

  • Movement-resistance gait rehabilitation device

GAIT BELT WITH ODOR CONTROL 54IN - 00733657227673

No Description
ALIMED, INC.
70257
In Commercial Distribution

  • 00733657227673 ()
2970008130

  • Movement-resistance gait rehabilitation device

GAIT BELT WITH ODOR CONTROL 70IN - 00733657227666

No Description
ALIMED, INC.
70256
In Commercial Distribution

  • 00733657227666 ()
2970008129

  • Movement-resistance gait rehabilitation device

GAIT/TRANSFER BELT METAL BUCKLE PINSTRIPE 70IN - 00733657223897

No Description
ALIMED, INC.
7083
In Commercial Distribution

  • 00733657223897 ()
2970008349

  • Movement-resistance gait rehabilitation device

Gait Belt - 00616784435411

Gait Belt- Plastic Buckle, Multi-Color, 60"x2"
DYNAREX CORPORATION
4354
In Commercial Distribution

  • 00616784435435 ()
  • 00616784435411 ()


  • Gait rehabilitation system harness

Gait Belt - 00616784435312

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

  • 00616784435336 ()
  • 00616784435312 ()


  • Gait rehabilitation system harness

Gait Belt - 00616784435213

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

  • 00616784435237 ()
  • 00616784435213 ()


  • Gait rehabilitation system harness

Gait Belt - 00616784434513

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

  • 00616784434537 ()
  • 00616784434513 ()


  • Gait rehabilitation system harness

Gait Belt - 00616784434414

Gait Belt, Antimicrobial, Metal Buckle, Blue and White
DYNAREX CORPORATION
4344
In Commercial Distribution

  • 00616784434438 ()
  • 00616784434414 ()


  • Gait rehabilitation system harness

GammaPro Angled Standard Probe - B619GPROSTDANGPROBE0

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

  • B619GPROSTDANGPROBE0 ()


  • Mobile gamma camera system

GammaPro Carry Case and Tablet - B619GPROCASETABL2

Table with installed software is used with wireless battery powered probes (different shapes and sizes) to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity.
Kubtec
K0017C01
In Commercial Distribution

  • B619GPROCASETABL2 ()


  • Mobile gamma camera system

GammaPro Hi-Sense Probe with Tablet and Carry Case - B619GPROHISKIT0

GammaPro Hi-Sense Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0019C02
In Commercial Distribution

  • B619GPROHISKIT0 ()


  • Mobile gamma camera system

GammaPro High Sensitivity Probe - B619GPROHISPROBE0

GammaPro High Sensitivity Probe used for wireless ionizing radiation detection.
Kubtec
K0019C01
In Commercial Distribution

  • B619GPROHISPROBE0 ()


  • Mobile gamma camera system

GammaPro Laparoscopic Probe - B619GPROLAPPROBE0

GammaPro Laparoscopic Probe used for wireless ionizing radiation detection.
Kubtec
K0020C01
In Commercial Distribution

  • B619GPROLAPPROBE0 ()


  • Mobile gamma camera system

GammaPro Laparoscopic Probe with Tablet and Carry Case - B619GPROLAPKIT0

GammaPro Laparoscopic Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0020C02
In Commercial Distribution

  • B619GPROLAPKIT0 ()


  • Mobile gamma camera system

GammaPro Standard Probe with Tablet Carry Case - B619GPROSTDKIT0

GammaPro Kit with Standard probe, Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0018C02
In Commercial Distribution

  • B619GPROSTDKIT0 ()


  • Mobile gamma camera system

GammaPro Straight Standard Probe - B619GPROSTDPROBE0

GammaPro Straight Standard Probe for wireless ionizing radiation detection.
Kubtec
K0018C01
In Commercial Distribution

  • B619GPROSTDPROBE0 ()


  • Mobile gamma camera system

Global Spinal Fixation System™ - 08800015946414

No Description
Innosys Co., Ltd.
SG0019
In Commercial Distribution

  • 08800015946414 ()


  • Bone graft packing block

Healing Solutions Harness - G505MRHSH0

Harness for Healing Solutions Robotic Trainer
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRHSH0 ()


  • Gait rehabilitation system harness
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