STERILUX AMD ST BULKY GZ 4.5x4.1YD 6P

GUDID 04052199500492

STERILUX AMD ST BULKY GZ 4.5x4.1YD 6P

PAUL HARTMANN AG

Wound-nonadherent dressing, permeable, antimicrobial
Primary Device ID04052199500492
NIH Device Record Key8bf3fbe0-682b-448a-90cd-b5b05d7ab87a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTERILUX AMD ST BULKY GZ 4.5x4.1YD 6P
Version Model Number15713135
Company DUNS315768788
Company NamePAUL HARTMANN AG
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 Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104052199500485 [Primary]
GS104052199500492 [Package]
Contains: 04052199500485
Package: [120 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-09
Device Publish Date2020-09-01

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