Bulline

GUDID 00850044093014

Steer Sourcing, Inc.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00850044093014
NIH Device Record Key3e7e9bef-5a47-4d09-9bd6-3b657ba935c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameBulline
Version Model NumberB3502
Company DUNS118153673
Company NameSteer Sourcing, Inc.
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 Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850044093014 [Primary]
GS100850044093069 [Package]
Package: Case [10 Units]
In Commercial Distribution

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 Date2022-10-25
Device Publish Date2022-10-17

On-Brand Devices [Bulline]

00850044093090B3505
00850044093038B3504
00850044093021B3503
00850044093014B3502
00850044093007B3501

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