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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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SC AT PELHAM EXTREMITY PACK
Cardinal Health 200, LLC
SOP23EPPL4
In Commercial Distribution

  • 50197106643042 ()
  • 10197106643044 ()
SOP23EPPL4

  • Orthopaedic surgical procedure kit, non-medicated, single-use
A collection of noninvasive devices intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other investigation.
PRIVAPATH DIAGNOSTICS LIMITED
UO305, UO01S
In Commercial Distribution

  • 00850024881327 ()
UO305, UO01S

  • Urine specimen collection kit IVD
A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.
PRIVAPATH DIAGNOSTICS LIMITED
UO01S
In Commercial Distribution

  • 00810111410748 ()


  • Urine specimen collection kit IVD
simpli-COLLECT Urine Collection Kit
ABBOTT MOLECULAR INC.
09N93-001
In Commercial Distribution

  • 30884999051400 ()
  • 00884999051409 ()
09N93-001

  • General specimen container IVD, no additive/medium
simpli-COLLECT Swab Collection Kit
ABBOTT MOLECULAR INC.
09R02-001
In Commercial Distribution

  • 30884999051349 ()
  • 00884999051348 ()
09R02-001

  • General-purpose absorbent tip applicator/swab, single-use
  • General specimen container IVD, no additive/medium
Assembled, tray packed, and sterilized at Oscor Caribe, then final packaged at Oscor, Inc.
MAINSTAY MEDICAL LIMITED
7M8145-006
Not in Commercial Distribution

  • 05391527772071 ()
8145

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
OPTIVISOR MAGNIFIER #DA-3
SONTEC INSTRUMENTS, INC.
1103-402
In Commercial Distribution

  • 00192896096226 ()

  • 1.75 Magnification at 14 Inches
1103-402

  • Spectacle-mounted magnifier
SC AT PELHAM KNEE ARTHRO PACK
Cardinal Health 200, LLC
SOP23KAPLB
In Commercial Distribution

  • 50195594374608 ()
  • 10195594374600 ()
SOP23KAPLB

  • Arthroscopic surgical procedure kit, non-medicated, single-use
SC AT PELHAM TOTAL HIP PACK
Cardinal Health 200, LLC
SOP23THPLB
In Commercial Distribution

  • 50195594374585 ()
  • 10195594374587 ()
SOP23THPLB

  • Orthopaedic surgical procedure kit, non-medicated, single-use
HT, ITC/ITE AT BE HIT
Oticon A/S
106-31-290-10
In Commercial Distribution

  • 05707131130822 ()


  • Air-conduction hearing aid, in-the-ear
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