MANUKAtex 10 x 122 cm

GUDID 05060188820512

MANUKAMED LIMITED PARTNERSHIP

Wound-nonadherent dressing, permeable, antimicrobial
Primary Device ID05060188820512
NIH Device Record Keyf70ca123-a637-4d5a-b469-61315e1282e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMANUKAtex 10 x 122 cm
Version Model NumberMM0012
Company DUNS594970245
Company NameMANUKAMED LIMITED PARTNERSHIP
Device Count4
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
GS105060188820512 [Unit of Use]
GS105060188820529 [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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