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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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Liquid Urine Control Dipstick - Negative, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
303-1
In Commercial Distribution

  • 10858512007034 ()
  • 30858512007038 ()

  • Total Volume: 30 Milliliter
303-1

  • Multiple urine analyte IVD, control
Liquid Urine Control Dipstick - Positive, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
301-2
In Commercial Distribution

  • 30858512007014 ()
  • 10858512007010 ()

  • Total Volume: 20 Milliliter
301-2

  • Multiple urine analyte IVD, control
Liquid Urine Control Dipstick - Negative, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
301-1
In Commercial Distribution

  • 30858512007007 ()
  • 10858512007003 ()

  • Total Volume: 20 Milliliter
301-1

  • Multiple urine analyte IVD, control
Voltage: AC 110-120V 60Hz, Max pressure: 95 psi (preset), Air flow at 0 psi: ~37 l/min, Air flow at 50 psi: ~17 l/min
Dynarex Corporation
33952
In Commercial Distribution

  • 00840117324008 ()
  • 00840117327498 ()


  • Medical device air compressor
Toric IOL Reference Marker Blades are positioned at 0, 90, 180 Degrees, Head is angled at 70 degrees, Round Knurled Handle, 98mm Overall Length, Titanium
Crestpoint Management Limited
PH9517T
In Commercial Distribution

  • G412PH9517T0 ()


  • Corneal marker, reusable
Swab Saline At Home Collection and Transport Kit, Cleveland Clinic Only
AERO-MED, LLC
CA33575
In Commercial Distribution

  • 50885380181205 ()
  • 10885380181207 ()
CA33575

  • Specimen mailer kit
Blood Culture Collection Kit, Robert Wood Johnson at New Brunswick Only
AERO-MED, LLC
CA10875
In Commercial Distribution

  • 50885380176164 ()
  • 10885380176166 ()
CA10875

  • Phlebotomy kit
Cobra Retractor, medium, 46mm blade at widest, 7" handle, 12" OL
Avalign Technologies, Inc.
1-6132
In Commercial Distribution

  • 00190776394677 ()


  • Hand-held surgical retractor, reusable
Sleeve Protector, ComforTech, White, Sonic Welded, Elastic at both ends, UNIV
Alpha Pro Tech, Inc.
MS-01J06-8TH
In Commercial Distribution

  • 20817583023050 ()
  • 10817583023053 ()
  • 00817583023056 ()
MS-01J06-8TH

  • Surgical sleeve cover
Sleeve Protector, ComforTech, White, Sonic Welded, Elastic at both ends, UNIV
Alpha Pro Tech, Inc.
MS-01J06-8
In Commercial Distribution

  • 20817583023043 ()
  • 10817583023046 ()
  • 00817583023049 ()
MS-01J06-8

  • Surgical sleeve cover
Sleeve Protector, ComforTech, White, Sonic Welded, Elastic at both ends, XL
Alpha Pro Tech, Inc.
MS-01J06-4
In Commercial Distribution

  • 20817583023036 ()
  • 10817583023039 ()
  • 00817583023032 ()
MS-01J06-4

  • Surgical sleeve cover
Sleeve Protector, NuTech, White, Sonic Welded, Elastic at both ends, UNIV
Alpha Pro Tech, Inc.
MS-01606-8
In Commercial Distribution

  • 20817583023012 ()
  • 10817583023015 ()
  • 00817583023018 ()
MS-01606-8

  • Surgical sleeve cover
Sleeve Protector, NuTech, White, Sonic Welded, Elastic at both ends, XL
Alpha Pro Tech, Inc.
MS-01606-4
In Commercial Distribution

  • 20817583023005 ()
  • 10817583023008 ()
  • 00817583023001 ()
MS-01606-4

  • Surgical sleeve cover
Sleeve Protector, GenPro, White, Serged Seams, Elastic at both ends, UNIV
Alpha Pro Tech, Inc.
MS-01135-8
In Commercial Distribution

  • 20817583022992 ()
  • 10817583022995 ()
  • 00817583022998 ()
MS-01135-8

  • Surgical sleeve cover
Oral Surgery Rongeur, #4A, 6 1/2", jaws at 35deg angle
Avalign Technologies, Inc.
1-22488
In Commercial Distribution

  • 00190776374518 ()


  • Dental rongeur
Dermatological and aesthetic laser device operating at 1064 and 532 nm.
QUANTA SYSTEM SPA
PCMS00354
In Commercial Distribution

  • 08059173396368 ()


  • Dermatological frequency-doubled solid-state laser system
PLIERS, OPERATIVE DEBAKEY AT FCPS/PLIERS OPERATIVE,MODIF. 16 CM, ANGELED
Helmut Zepf Medizintechnik GmbH
50.229.16
In Commercial Distribution

  • EZPF50229160 ()
50.229.16

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
McKenty Septum Elevator 5-1/2" (13.8cm), curved at tip, 4mm wide
Hayden Medical, Inc.
210-062
In Commercial Distribution

  • 00840319721681 ()
210-062

  • ENT elevator
Kleegman Dilator 10-3/4" (26.9cm), 1-3mm at tips, double ended TEFLON
Hayden Medical, Inc.
290-003T
In Commercial Distribution

  • 00840319708286 ()
290-003T

  • Fixed-diameter cervical dilator, reusable
Potts-Smith Dressing Forceps 12" (30cm), serrated, NON-CONDUCTIVE, exposed at both ends
Hayden Medical, Inc.
120-159NC
In Commercial Distribution

  • 00840319739730 ()
120-159NC

  • Dressing/utility forceps, tweezers-like, reusable
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