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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For microscopic counting of Sperms. (100 Tests)
BIOANALYTIC GmbH, biomed. Analysentechnik
003604-6100
In Commercial Distribution

  • 04061609000026 ()
  • 04061609000545 ()


  • Sperm concentration indicator IVD, reagent
No Description
Joline GmbH & Co. KG
US9503
In Commercial Distribution

  • 04250203940894 ()


  • General-purpose syringe, single-use
No Description
BONART CO., LTD.
LCC-120A
In Commercial Distribution

  • 04719873120666 ()


  • Dental power tool system handpiece, line-powered
No Description
LIFE TECHNOLOGIES CORPORATION
003005
Not in Commercial Distribution

  • 10190302007504 ()


  • Buffered sample diluent IVD, manual
No Description
Bird & Cronin, LLC
08143502
In Commercial Distribution

  • 00610570012602 ()


  • Traction system head halter
No Description
FISHER SCIENTIFIC COMPANY L.L.C.
23038033
In Commercial Distribution

  • 10613647000653 ()
  • 00613647000656 ()


  • Faecal occult blood IVD, kit, rapid colorimetric, clinical
No Description
QUINTRON INSTRUMENT COMPANY, INC.
QT00991-P
In Commercial Distribution

  • 00850010197852 ()
  • 00850010197050 ()
QT00991-P

  • Breath specimen container IVD
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600873-001
In Commercial Distribution

  • J00716008730011 ()
1600873-001

  • Dental laboratory drilling system handpiece
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600598-001
In Commercial Distribution

  • J00716005980011 ()
1600598-001

  • Dental power tool system handpiece, remotely-driven
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
353
In Commercial Distribution

  • 00842430112737 ()
353

  • Traction weight
No Description
DARCO INTERNATIONAL, INC.
E62653
In Commercial Distribution

  • 10609271611501 ()
  • 00609271611504 ()
  • 20609271611508 ()
E62653

  • Knee immobilizer
No Description
SIZEWISE RENTALS, L.L.C.
DAC20
In Commercial Distribution

  • 00845699001309 ()


  • Commode, manual
No Description
OXOID LIMITED
AN0020C
In Commercial Distribution

  • 05032384069132 ()


  • Atmospheric generation kit IVD
No Description
ELECTRO-CAP INTERNATIONAL INC
I1-2-20ELEC
In Commercial Distribution

  • 00811478012538 ()
I1-2-20ELEC

  • Analytical scalp lead
No Description
ELECTRO-CAP INTERNATIONAL INC
I1-1
In Commercial Distribution

  • 00811478012507 ()
I1-1

  • Analytical scalp lead
No Description
ELECTRO-CAP INTERNATIONAL INC
I1-3-20ELEC
In Commercial Distribution

  • 00811478012569 ()
I1-3-20ELEC

  • Analytical scalp lead
Comfort Band Non-Sterile 20" Green
Tz Medical, Inc.
CB-7520G
In Commercial Distribution

  • 00811331011821 ()


  • Vascular puncture haemostasis arm clamp/band, single-use
M4 Valor Wheelchair 20”, Universal armrests, Swing-away Footrests
Drive Devilbiss Healthcare
GVPLA420FBUA RAD-SF
In Commercial Distribution

  • 00822383024615 ()


  • Push-rim manual wheelchair, bariatric
Blister of 6 units
NUSMILE, LTD.
ZHEDST3120
In Commercial Distribution

  • 00810118100987 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZHEDST2520
In Commercial Distribution

  • 00810118100871 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZHEDST2120
In Commercial Distribution

  • 00810118100765 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZKFLEX3120
In Commercial Distribution

  • 00810118100666 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZKFLEX2520
In Commercial Distribution

  • 00810118100581 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZKFLEX2120
In Commercial Distribution

  • 00810118100505 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZKFILE3120
In Commercial Distribution

  • 00810118100413 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZKFILE2520
In Commercial Distribution

  • 00810118100291 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Blister of 6 units
NUSMILE, LTD.
ZKFILE2120
In Commercial Distribution

  • 00810118100178 ()


  • Rotary/reciprocating endodontic file/rasp, single-use
Tinto Cytokeratin 20 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB53880 ()
BSB 5388

  • Cytokeratin IVD, antibody
Tinto Cytokeratin 20 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB53870 ()
BSB 5387

  • Cytokeratin IVD, antibody
Tinto Cytokeratin 20 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB53860 ()
BSB 5386

  • Cytokeratin IVD, antibody
Tinto Cytokeratin 20 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB67040 ()
BSB 6704

  • Cytokeratin IVD, antibody
Tinto Cytokeratin 20 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB67030 ()
BSB 6703

  • Cytokeratin IVD, antibody
Tinto Cytokeratin 20 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB67020 ()
BSB 6702

  • Cytokeratin IVD, antibody
3 units
NUSMILE, LTD.
UDMO2004
In Commercial Distribution

  • 00810092938750 ()


  • Manual non-rotary dental instrument handle
3 units
NUSMILE, LTD.
UDMS2002
In Commercial Distribution

  • 00810092938705 ()


  • Manual non-rotary dental instrument handle
No Description
Baylis Medical Technologies Inc
PSZ-400-305
Not in Commercial Distribution



  • Suturing unit, single-use
The Provox Vega Plug is a first-aid tool for temporarily stopping leakage through a Provox Vega voice prosthesis. The device is inserted into the opening of the Provox Vega voice prosthesis and hence blocking any leakage through the valve.
Atos Medical AB
8129
In Commercial Distribution

  • 07331791005954 ()

  • Voice Prosthesis Compatibility Fits 20 Fr voice prosthesis
8129

  • Tracheoesophageal speech valve occluder, non-valved
No Description
Trilliant Surgical, LLC
300-85-012
In Commercial Distribution

  • 00810028395640 ()


  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Trilliant Surgical, LLC
300-85-009
In Commercial Distribution

  • 00810028395619 ()


  • Orthopaedic fixation plate, non-bioabsorbable
Ventilator Non-continuous (Respirator)
Breas Medical AB
US
Not in Commercial Distribution

  • 07321822060168 ()
  • 07321822060007 ()
206000

  • Home CPAP unit
Ventilator Non-continuous (Respirator)
Breas Medical AB
US
Not in Commercial Distribution

  • 07321822050169 ()
  • 07321822050008 ()
205000

  • Home CPAP unit
No Description
Berman Instruments LLC
CSO20
Not in Commercial Distribution

  • 00810060722299 ()


  • Instrument tray, reusable
No Description
BIOPRO, INC.
10724
In Commercial Distribution

  • M209107240 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
No Description
BIO CONCEPT Co., Ltd.
031030
In Commercial Distribution

  • 06947600301134 ()


  • Dental implant system
Wart Freezer Cryogenic Treatment 1-Step Wart Remover
MEIJER, INC.
4080389
In Commercial Distribution

  • 10713733086148 ()
  • 00713733086141 ()

  • Height: 155 Millimeter
4080389

  • Wart-removal cryogenic kit
Wart Freezer 1-step wart remover
FOOD LION, LLC
355850
Not in Commercial Distribution

  • 10725439992760 ()
  • 00725439992763 ()

  • Height: 155 Millimeter
355850

  • Wart-removal cryogenic kit
Wart Freezer 1-Step Wart Remover
WAL-MART STORES, INC.
563008516
Not in Commercial Distribution

  • 20681131162702 ()
  • 00681131162708 ()

  • Height: 155 Millimeter
563008516

  • Wart-removal cryogenic kit
QualityREG CO2 Pressure Regulator, Connection ISO 5145, NIST incl. Pressure gauge
DEHAS Medical Systems GmbH
DM-ISO-MS-NIST-CO2
In Commercial Distribution

  • 04251411705893 ()
DM-ISO-MS-NIST-CO2

  • Non-fixed medical gas cylinder regulator
QualityREG CO2 Pressure Regulator, Connection DIN EN ISO 407 PIN INDEX, NIST incl. Pressure gauge
DEHAS Medical Systems GmbH
DM-PIN-MS-NIST-CO2
In Commercial Distribution

  • 04251411705886 ()
DM-PIN-MS-NIST-CO2

  • Non-fixed medical gas cylinder regulator
QualityREG CO2 Pressure Regulator, Connection DIN ISO 477-6, NIST incl. Pressure gauge
DEHAS Medical Systems GmbH
DM-DIN6-MS-NIST-CO2
In Commercial Distribution

  • 04251411705879 ()


  • Non-fixed medical gas cylinder regulator
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