Sterilization Tray

GUDID 08404535019919

BR-9709

Peter Brasseler Holdings, LLC

Instrument tray, reusable
Primary Device ID08404535019919
NIH Device Record Key2ec4a0fd-8be7-478f-b20d-5a79a6af04bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterilization Tray
Version Model NumberBR-9709
Company DUNS082080136
Company NamePeter Brasseler Holdings, LLC
Device Count1
DM Exempttrue
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108404535019919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRGWrap, sterilization

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08404535019919]

Moist Heat or Steam Sterilization


[08404535019919]

Moist Heat or Steam Sterilization


[08404535019919]

Moist Heat or Steam Sterilization


[08404535019919]

Moist Heat or Steam Sterilization


[08404535019919]

Moist Heat or Steam Sterilization


[08404535019919]

Moist Heat or Steam Sterilization


[08404535019919]

Moist Heat or Steam Sterilization


[08404535019919]

Moist Heat or Steam Sterilization


[08404535019919]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-22
Device Publish Date2025-09-12

On-Brand Devices [Sterilization Tray]

08404535019520BR-9708K
08404535019919BR-9709

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.