Sense8x

GUDID 00810054580751

Nitrile Exam Gloves

Stauffer Manufacturing Company

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00810054580751
NIH Device Record Key3d36f589-20c8-4356-a4a4-58a66759c5cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSense8x
Version Model Number8005PFB 2X
Company DUNS002336204
Company NameStauffer Manufacturing Company
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS100810054580751 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZAPolymer Patient Examination Glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-01-12
Device Publish Date2023-01-04

On-Brand Devices [Sense8x]

00810054580751Nitrile Exam Gloves
00810054580737Nitrile Exam Gloves
00810054580713Nitrile Exam Gloves
00810054580706Nitrile Exam Gloves
00810054580683Nitrile Exam Gloves

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