Medical Face Shield

GUDID 00810050851985

Medical Face Shield

TYPENEX MEDICAL LLC

Face splash shield, single-use Face splash shield, single-use Face splash shield, single-use
Primary Device ID00810050851985
NIH Device Record Keyfa0c72b3-7d55-4080-b1a3-ddbb5c60fe67
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedical Face Shield
Version Model NumberFS0101
Company DUNS600850213
Company NameTYPENEX MEDICAL LLC
Device Count200
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810050851978 [Unit of Use]
GS100810050851985 [Primary]

FDA Product Code

LYUAccessory, Surgical Apparel

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-06
Device Publish Date2022-11-28

Devices Manufactured by TYPENEX MEDICAL LLC

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00810050855549 - Tourniquets2024-05-03 Tourniquet 3/4" x 18", Textured, Rolled & Banded, Orange
00810050855563 - Tourniquets2024-05-03 Tourniquet 1" x 18", Textured, Flat, Blue
00810050855587 - Tourniquets2024-05-03 Tourniquet 1" x 18", Textured, Flat, Orange
10810050855256 - CultureSafe2023-06-27 Blood Culture Bottle Dispensing Device
00810050851985 - Medical Face Shield2022-12-06Medical Face Shield
00810050851985 - Medical Face Shield2022-12-06 Medical Face Shield

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