Bulline

GUDID 00850044093090

Steer Sourcing, Inc.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00850044093090
NIH Device Record Key70731dde-cecb-4695-9378-a8fb9a57f092
Commercial Distribution StatusIn Commercial Distribution
Brand NameBulline
Version Model NumberB3505
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
GS100850044093045 [Primary]
GS100850044093090 [Package]
Contains: 00850044093045
Package: [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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