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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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iScreen™ - 00817405023554

7 PANEL E&I OF CUBE AMP50/COC20/MET50/OPI40/OXY20/PCP10/THC40
Instant Technologies, Inc.
ABTOFCUBE0701A
In Commercial Distribution

  • 30817405023555 ()
  • 00817405023554 ()
  • 10817405023551 ()
ABTOFCUBE0701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

KONG-TL VBR E, Expandable Body, XL, Ø 19 mm x 33 - 49 mm - 07640164847450

KONG-TL VBR E, Expandable Body, XL, Ø 19 mm x 33 - 49 mm
icotec AG
12-90-1933-9
In Commercial Distribution

  • 07640164847450 ()
12-90-1933-9

  • Vertebral body prosthesis

KONG-TL VBR E, Expandable Body, L, Ø 19 mm x 27 - 37 mm - 07640164847443

KONG-TL VBR E, Expandable Body, L, Ø 19 mm x 27 - 37 mm
icotec AG
12-90-1927-9
In Commercial Distribution

  • 07640164847443 ()
12-90-1927-9

  • Vertebral body prosthesis

KONG-TL VBR E, Expandable Body, M, Ø 19 mm x 23 - 30 mm - 07640164847436

KONG-TL VBR E, Expandable Body, M, Ø 19 mm x 23 - 30 mm
icotec AG
12-90-1923-9
In Commercial Distribution

  • 07640164847436 ()
12-90-1923-9

  • Vertebral body prosthesis

KONG-TL VBR E, Expandable Body, S, Ø 19 mm x 20 - 24 mm - 07640164847429

KONG-TL VBR E, Expandable Body, S, Ø 19 mm x 20 - 24 mm
icotec AG
12-90-1920-9
In Commercial Distribution

  • 07640164847429 ()
12-90-1920-9

  • Vertebral body prosthesis

Pulmonary Function Test Kit E - 00817081028348

Pulmonary Function Test Kit E, VBMax34E w/ Foam Nose Clip and Rubber Mouthpiece
A-M SYSTEMS, LLC
Pulmonary Function Test Kit E - 189124
In Commercial Distribution

  • 00817081028355 ()
  • 00817081028348 ()
189124

  • Pulmonary function testing kit

NOA Medical Industries, Inc. - 00817492012806

BED - SC+ Hosp- Scale, E CPR, Exit Alarm, C Lk Sys- 84x35 (Gray)
Hoffmann NOA Medical Industries, LLC
1055030GRY
In Commercial Distribution

  • 00817492012806 ()


  • Basic electric hospital bed

NOA Medical Industries, Inc. - 00817492012677

BED - SC+ Hosp- Scale, E CPR, Exit Alarm, C Lk Sys- 80x35 (Gray)
Hoffmann NOA Medical Industries, LLC
1055029GRY
In Commercial Distribution

  • 00817492012677 ()


  • Basic electric hospital bed

BioSign® RC hCG S/U card - 10743816000716

BioSign® RC hCG S/U card; 35 Test kit; E Device; CE
PRINCETON BIOMEDITECH CORPORATION
BSP-122-35-01
In Commercial Distribution

  • 10743816000716 ()
BSP-122-35-01

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

iTotal Identity CR - M572RCR020000E141

ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPOLY XE, LATERAL, E, LEFT & RIGHT
Conformis, Inc.
RCR020000E14
In Commercial Distribution

  • M572RCR020000E141 ()
RCR-020-000E

  • Tibial insert
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