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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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EPITOME - H671CBE2500

Disposable Electrosurgical Electrode, 3/4" (19mm) Blade Length, Extended 4" (10cm) Shaft Length, 0.2mm Wire Diameter
UTAH MEDICAL PRODUCTS, INC.
Epitome .2
In Commercial Distribution

  • H671CBE2502 ()
  • H671CBE2501 ()
  • H671CBE2500 ()

  • Wire Diameter - 0.2 mm
  • Shaft Length - 4" (10cm)
  • Blade Length - 0.75" (19mm)
CBE-250

  • Open-surgery electrosurgical electrode, monopolar, single-use

EPITOME - H671CBE2200

Disposable Electrosurgical Electrode with ZapGuard, 0.16" (4mm) Blade Length, 2" (5cm) Bendable Shaft Length, 0.2mm Wire Diameter
UTAH MEDICAL PRODUCTS, INC.
Epitome .2 with ZapGuard
In Commercial Distribution

  • H671CBE2202 ()
  • H671CBE2201 ()
  • H671CBE2200 ()

  • Wire Diameter - 0.2 mm
  • Shaft Length - 2" (5cm)
  • Blade Length - 0.16" (4mm)
CBE-220

  • Open-surgery electrosurgical electrode, monopolar, single-use

EPITOME - H671CBE2100

Disposable Electrosurgical Electrode, 0.16" (4mm) Blade Length, 2" (5cm) Bendable Shaft Length, 0.2mm Wire Diameter
UTAH MEDICAL PRODUCTS, INC.
Epitome .2
In Commercial Distribution

  • H671CBE2102 ()
  • H671CBE2101 ()
  • H671CBE2100 ()

  • Wire Diameter - 0.2 mm
  • Shaft Length - 2" (5cm)
  • Blade Length - 0.16" (4mm)
CBE-210

  • Open-surgery electrosurgical electrode, monopolar, single-use

EPITOME - H671CBE2000

Disposable Electrosurgical Electrode, 3/4" (19mm) Blade Length, Standard 2" (5cm) Shaft Length, 0.2mm Wire Diameter
UTAH MEDICAL PRODUCTS, INC.
Epitome .2
In Commercial Distribution

  • H671CBE2002 ()
  • H671CBE2001 ()
  • H671CBE2000 ()

  • Wire Diameter - 0.2 mm
  • Shaft Length - 2" (5cm)
  • Blade Length - 0.75" (19mm)
CBE-200

  • Open-surgery electrosurgical electrode, monopolar, single-use

EPITOME - H671CBE1500

Disposable Electrosurgical Electrode, 3/4" (19mm) Blade Length, Extended 4" (10cm) Shaft Length, 0.4mm Wire Diameter
UTAH MEDICAL PRODUCTS, INC.
Epitome .4
In Commercial Distribution

  • H671CBE1502 ()
  • H671CBE1501 ()
  • H671CBE1500 ()

  • Wire Diameter - 0.4 mm
  • Shaft Length - 4" (10cm)
  • Blade Length - 0.75" (19mm)
CBE-150

  • Open-surgery electrosurgical electrode, monopolar, single-use

EPITOME - H671CBE1000

Disposable Electrosurgical Electrode, 3/4" (19mm) Blade Length, Standard 2" (5cm) Shaft Length, 0.4mm Wire Diameter
UTAH MEDICAL PRODUCTS, INC.
Epitome .4
In Commercial Distribution

  • H671CBE1002 ()
  • H671CBE1001 ()
  • H671CBE1000 ()

  • Wire Diameter - 0.4 mm
  • Shaft Length - 2" (5cm)
  • Blade Length - 0.75" (19mm)
CBE-100

  • Open-surgery electrosurgical electrode, monopolar, single-use

EPITOME - H671CB42000

Disposable Electrosurgical Electrode, 3/4" (19mm) Blade Length, Standard 2" (5cm) Shaft Length, (EURO 4mm Shaft Diameter), 0.2mm Wire Diameter
UTAH MEDICAL PRODUCTS, INC.
Epitome .2
In Commercial Distribution

  • H671CB42002 ()
  • H671CB42001 ()
  • H671CB42000 ()

  • Wire Diameter - 0.2 mm
  • Shaft Diameter - 4 mm
  • Blade Length - 0.75" (19mm)
CB4-200

  • Open-surgery electrosurgical electrode, monopolar, single-use

EPITOME - H671CB41000

Disposable Electrosurgical Electrode, 3/4" (19mm) Blade Length, Standard 2" (5cm) Shaft Length, (EURO 4mm Shaft Diameter), 0.4mm Wire Diameter
UTAH MEDICAL PRODUCTS, INC.
Epitome .4
In Commercial Distribution

  • H671CB41002 ()
  • H671CB41001 ()
  • H671CB41000 ()

  • Wire Diameter - 0.4 mm
  • Shaft Diameter - 4 mm
  • Blade Length - 0.75" (19mm)
CB4-100

  • Open-surgery electrosurgical electrode, monopolar, single-use

DISPIRO - H6719502450

Disposable Spirometer System Kit with 02401, 02020, 02013
UTAH MEDICAL PRODUCTS, INC.
Custom
In Commercial Distribution

  • H6719502452 ()
  • H6719502451 ()
  • H6719502450 ()
950-245

  • Gasometer

Fascile Continuous Peripheral Nerve Block Set - B372500001011

Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of an open tip catheter over a needle. Fascile kit is comprised of different key components required to complete the Peripheral Nerve Block procedure.
Solo-Dex, Inc
70mm, Kit with filter
Not in Commercial Distribution

  • B3723000301015 ()
  • B372500001011 ()
  • B3721001385 ()

  • Length: 70 Millimeter
500001-01

  • Peripheral nerve-block sharp needle

Perineologic - B371P10010

The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, single use, disposable, needle guide consisting, of a Carriage and a Rail Clamp Assembly and Access Needle, that is intended for use with a cylindrical style trans-rectal ultrasound transducer (0.7” to .85” diameter BK #8658 or equivalent) associated with a BK ProFocus ultrasound system and a biopsy needle. The PrecisionPoint™ Transperineal Access System is designed to stabilize a Perineologic Access Needle on the anatomy as a means to properly guide the anatomical placement of a biopsy needle into the prostate or other soft tissues through the use of ultrasound-assisted guidance.
Corbin Clinical Resources, LLC
1
In Commercial Distribution

  • B371P10010 ()
  • B371P10012 ()
  • B371P10014 ()


  • Needle guide, single-use

ESI GloSpec - B3961403100

Single use vaginal speculum with built in light source size small
FTT MEDICAL, INC.
140310
In Commercial Distribution

  • B3961403102 ()
  • B3961403100 ()
  • B3961403101 ()
14-0310

  • Vaginal speculum, single-use

MicroLyte Ag - B519910020

Gelling fiber wound dressing, 4"x4"
IMBED BIOSCIENCES, INC
91002
Not in Commercial Distribution

  • B519910022 ()
  • B519910021 ()
  • B519910020 ()

  • Area/Surface Area: 16 Square inch
91002

  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial

Microlyte AG - B519910010

Gelling fiber wound dressing, 2" x 2"
IMBED BIOSCIENCES, INC
91001
Not in Commercial Distribution

  • B519910012 ()
  • B519910011 ()
  • B519910010 ()

  • Area/Surface Area: 4 Square inch
91001

  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial

ACETONE BLANK - B800ACEBLKSFBSRHS0

ACETONE BLANK
UTAK LABORATORIES, INC.
ACE BLK S F BSRHS
In Commercial Distribution

  • B800ACEBLKSFBSRHS5 ()
  • B800ACEBLKSFBSRHS0 ()
  • B800ACEBLKSFBSRHS55 ()

  • Total Volume: 1 Milliliter
ACE BLK S F BSRHS

  • Multiple-type clinical chemistry analyte profile IVD, control

Soviflex - B79510010

Post-parturition vaginal retractor intended to retract the vaginal walls following childbirth for improved visualization and access during surgical repair (e.g. suturing) of vaginal tears.
Birch Concepts LLC
1001
In Commercial Distribution

  • B79510011 ()
  • B79510010 ()
  • B79510012 ()
1001

  • Post-parturition vaginal retractor

SPEAX Patch - B792FGN002

Patch for use with the SPEAX Communication System
ATAIA INC.
FGN-002
In Commercial Distribution

  • B792FGN003 ()
  • B792FGN002 ()
  • B792FGN012 ()
FGN002

  • Voice amplification system

OLO CBC Test Kit - B787TK10

A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
S.D. SIGHT DIAGNOSTICS LTD
TK1
In Commercial Distribution

  • B787TK10 ()
  • B787TK11 ()
  • B787TK12 ()


  • Full blood count IVD, kit, cell count

Great Glove - B754SNM50020E0

Soft Nitrile Powder Free Medical Gloves Size Extra Large
GD CARE INC.
SNM50020E
In Commercial Distribution

  • B754SNM50020E1 ()
  • B754SNM50020E0 ()
  • B754SNM50020E2 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Great Glove - B754SNM50010E0

Soft Nitrile Powder Free Medical Gloves Size Medium
GD CARE INC.
SNM50010E
In Commercial Distribution

  • B754SNM50010E1 ()
  • B754SNM50010E0 ()
  • B754SNM50010E2 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Great Glove - B754SNM50005E0

Soft Nitrile Powder Free Medical Gloves Size Small
GD CARE INC.
SNM50005E
In Commercial Distribution

  • B754SNM50005E1 ()
  • B754SNM50005E0 ()
  • B754SNM50005E2 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Great Glove - B754SBLKNM520E0

Black Nitrile Powder Free Medical Gloves Size Extra Large
GD CARE INC.
SBLK-NM520E
In Commercial Distribution

  • B754SBLKNM520E1 ()
  • B754SBLKNM520E0 ()
  • B754SBLKNM520E2 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Great Glove - B754SBLKNM515E0

Black Nitrile Powder Free Medical Gloves Size Large
GD CARE INC.
SBLK-NM515E
In Commercial Distribution

  • B754SBLKNM515E1 ()
  • B754SBLKNM515E0 ()
  • B754SBLKNM515E2 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Great Glove - B754SBLKNM510E0

Black Nitrile Powder Free Medical Gloves Size Medium
GD CARE INC.
SBLK-NM510E
In Commercial Distribution

  • B754SBLKNM510E1 ()
  • B754SBLKNM510E0 ()
  • B754SBLKNM510E2 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Great Glove - B754SBLKNM505E0

Black Nitrile Powder Free Medical Gloves Size Small
GD CARE INC.
SBLK-NM505E
In Commercial Distribution

  • B754SBLKNM505E1 ()
  • B754SBLKNM505E0 ()
  • B754SBLKNM505E2 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Great Glove - B754SBLKNM500E0

Black Nitrile Powder Free Medical Gloves Size Extra Small
GD CARE INC.
SBLK-NM500E
In Commercial Distribution

  • B754SBLKNM500E1 ()
  • B754SBLKNM500E0 ()
  • B754SBLKNM500E2 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Care - B754ON50025

ON Nitrile Powder Free Medical Gloves Size Extra Extra Large
GD CARE INC.
ON50025
In Commercial Distribution

  • B754ON500251 ()
  • B754ON50025 ()
  • B754ON500252 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Care - B754ON50020

ON Nitrile Powder Free Medical Gloves Size Extra Large
GD CARE INC.
ON50020
In Commercial Distribution

  • B754ON500201 ()
  • B754ON50020 ()
  • B754ON500202 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Care - B754ON50015

ON Nitrile Powder Free Medical Gloves Size Large
GD CARE INC.
ON50015
In Commercial Distribution

  • B754ON500151 ()
  • B754ON50015 ()
  • B754ON500152 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Care - B754ON50010

ON Nitrile Powder Free Medical Gloves Size Medium
GD CARE INC.
ON50010
In Commercial Distribution

  • B754ON500101 ()
  • B754ON50010 ()
  • B754ON500102 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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