BPCO Ointment

GUDID 00371351014603

Class I (general controls), 510(k) exempt medical device with a product code of NAD. Per the Code of Federal Regulations, it is regulated under 21 CFR 878.4020 as an occlusive wound dressing.

Brookfield Pharmaceuticals, Llc

Skin semi-occlusive dressing, non-antimicrobial
Primary Device ID00371351014603
NIH Device Record Keydd1fad18-ac42-480c-b01f-9fdc42107736
Commercial Distribution StatusIn Commercial Distribution
Brand NameBPCO Ointment
Version Model Number1
Company DUNS080592685
Company NameBrookfield Pharmaceuticals, Llc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100371351014603 [Primary]

FDA Product Code

NADDressing, Wound, Occlusive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-23
Device Publish Date2023-11-15

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