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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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KLARITY MEDICAL - 00817355024472

Custom Die cut Mask 10.5 x 13 in.
Klarity Medical Products, LLC
R-2436CU
In Commercial Distribution

  • 00817355024472 ()


  • Patient positioning thermoplastic mould material

JAS Diagnostics - 00817274020913

AST PALS BULK (in 20 dry Liter bottles)
DREW SCIENTIFIC, INC.
AST2-BUP
In Commercial Distribution

  • 00817274020913 ()


  • Aspartate aminotransferase (AST) isoenzyme IVD, control

Exact Medical Manufacturing, Inc. - 00817602021599

Surgical Gown, STD, AAMI IV, XX-Lge, Set in-
EXACT MEDICAL MANUFACTURING, INC.
40141
Not in Commercial Distribution

  • 00817602021605 ()
  • 00817602021599 ()
40141

  • Surgical gown, single-use

Exact Medical Manufacturing, Inc. - 00817602021575

Surgical Gown, STD, AAMI IV, X-Lge, Set in-
EXACT MEDICAL MANUFACTURING, INC.
40131
Not in Commercial Distribution

  • 00817602021582 ()
  • 00817602021575 ()
40131

  • Surgical gown, single-use

Exact Medical Manufacturing, Inc. - 00817602021551

Surgical Gown, AAMI IV, STD, Lge, Set in-
EXACT MEDICAL MANUFACTURING, INC.
40121
Not in Commercial Distribution

  • 00817602021568 ()
  • 00817602021551 ()
40121

  • Surgical gown, single-use

Exact Medical Manufacturing, Inc. - 00817602021414

SMS Surgical Gown STD X-Lge, X-Lng, Set in-
EXACT MEDICAL MANUFACTURING, INC.
30151B
Not in Commercial Distribution

  • 00817602021421 ()
  • 00817602021414 ()
30151B

  • Patient surgical drape, single-use

Exact Medical Manufacturing, Inc. - 00817602021452

SMS Surgical Gown Fabric Reinf X-Lge, Set in-
EXACT MEDICAL MANUFACTURING, INC.
30231
Not in Commercial Distribution

  • 00817602021469 ()
  • 00817602021452 ()
30231

  • Patient surgical drape, single-use

Exact Medical Manufacturing, Inc. - 00817602021438

SMS Surgical Gown Fabric Reinf, Lge, Set in-
EXACT MEDICAL MANUFACTURING, INC.
30221
Not in Commercial Distribution

  • 00817602021445 ()
  • 00817602021438 ()
30221

  • Patient surgical drape, single-use

Essix A+® - D74610060251

Essix A+® Plastic - .06 in 125mm SQ
DENTSPLY SIRONA ORTHODONTICS INC.
10060-25
Not in Commercial Distribution

  • D74610060251 ()
  • D74610060250 ()
10060-25

  • Dental appliance fabrication material, thermoplastic

EPIPHANY - B528101605030

5MM X 12 IN ANGLE RT PITUITARY RONGEUR
PANTHEON SPINAL, LLC
1
In Commercial Distribution

  • B528101605030 ()

  • Length: 12 Inch
  • Width: 5 Millimeter
1016-0503

  • Orthopaedic joint/limb rongeur
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