SHEFA Block

GUDID 10860008457414

Shefa Solutions Inc.

Endoscopic bite block, basic, single-use
Primary Device ID10860008457414
NIH Device Record Key17251d69-1725-4684-9d71-20cd0bf1645a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSHEFA Block
Version Model Number1
Company DUNS118646521
Company NameShefa Solutions Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008457417 [Primary]
GS110860008457414 [Package]
Contains: 00860008457417
Package: Inner Box [50 Units]
In Commercial Distribution
GS120860008457411 [Package]
Package: Outer Box [5 Units]
In Commercial Distribution

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-04-29

Devices Manufactured by Shefa Solutions Inc.

00860008457431 - SHEFA Forcep2022-05-09 FORCEPS, BIOPSY, NON-ELECTRIC
10860008457414 - SHEFA Block2022-05-09
10860008457414 - SHEFA Block2022-05-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.