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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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SUPER SHEATH 2.1SUPER SHEATH 2.1 - 00884908143553

5.5F (1.9MM ID) X 5CM PTFE5.5F ( TEARAWAYTEARAWAY
Medical Components, Inc.
DVS555
In Commercial Distribution

  • 50884908143558 ()
  • 00884908143553 ()
DVS555

  • Vascular catheter introduction needle

SUPER SHEATH 2.1SUPER SHEATH 2.1 - 00884908129151

5.5F(1.9MM ID) X 10CM PTFE TEARAWAY
Medical Components, Inc.
VS5510
Not in Commercial Distribution

  • 50884908129156 ()
  • 00884908129151 ()


  • Vascular catheter introduction needle

SUPER SHEATH 2.1SUPER SHEATH 2.1 - 00884908129144

4.5F (1.0MM ID) X 10CM PTFE TEARAWAY
Medical Components, Inc.
VS4510
Not in Commercial Distribution

  • 50884908129149 ()
  • 00884908129144 ()


  • Vascular catheter introduction needle

Focal 44 Sublative iD (200 Pulses) - 00817495023779

Focal 44 Sublative iD, (200 Pulse,Green)
Candela Corporation
AS79354
In Commercial Distribution



  • Multi-modality skin surface treatment system

GAS4 module,Auto ID - 06944904006550

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
6800-30-50844
In Commercial Distribution

  • 06944904006550 ()


  • Patient monitoring system module, multiple-gas

RAPID ID 32 STREP - 03573026588625

rapid ID 32 STREP is a standardized system for the identification of streptococci and enterococci, and those most common related organisms, in 4 hours
BIOMERIEUX SA
RAPID ID 32 STREP
In Commercial Distribution

  • 03573026066536 ()
  • 03573026588625 ()


  • Multiple Streptococcus bacterial species culture isolate identification IVD, kit

RAPID ID 32 A - 03573026588564

rapid ID 32 A is a standardized system for the identification of anaerobes in 4 hours
BIOMERIEUX SA
RAPID ID 32 A
In Commercial Distribution

  • 03573026066420 ()
  • 03573026588564 ()


  • Multiple anaerobic bacteria species culture isolate identification IVD, kit

CaStar Cap, 22mm ID - 08058323016606

No Description
Intersurgical Incorporated
STR/019
In Commercial Distribution

  • 08058323030831 ()
  • 08058323016606 ()


  • Straight/elbow breathing circuit connector, single-use

ID NOW COVID-19 2.0 - 00811877011354

A rapid, automated, molecular test for the qualitative detection of COVID-19 viral nucleic acid in anterior nasal swab and nasopharyngeal swab specimens.
Alere Scarborough, Inc.
192-000
In Commercial Distribution

  • 00811877011354 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

ID NOW™ Instrument - 00811877010616

The ID NOW™ Instrument is a portable, fluorescence based instrument intended to be used for the processing and analysis of Abbott molecular diagnostic assays.
Alere Scarborough, Inc.
EQ00200XS
In Commercial Distribution

  • 00811877010616 ()


  • Isothermal nucleic acid amplification analyser IVD, laboratory
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