MANUKAtex 10 x 12.5 cm

GUDID 05060188820451

MANUKAMED LIMITED PARTNERSHIP

Wound-nonadherent dressing, permeable, antimicrobial
Primary Device ID05060188820451
NIH Device Record Key64126cf5-0100-42f8-861c-16fa95bbe711
Commercial Distribution StatusIn Commercial Distribution
Brand NameMANUKAtex 10 x 12.5 cm
Version Model NumberMM0010
Company DUNS594970245
Company NameMANUKAMED LIMITED PARTNERSHIP
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060188820451 [Unit of Use]
GS105060188820468 [Primary]

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 Date2020-05-22
Device Publish Date2020-05-14

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