MANUKAhd 10 x 12.5 cm

GUDID 05060188820734

MANUKAMED LIMITED PARTNERSHIP

Exudate-absorbent dressing, non-gel, antimicrobial, sterile
Primary Device ID05060188820734
NIH Device Record Keyde338c15-57f8-48ca-8b39-1e10c82e8d6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMANUKAhd 10 x 12.5 cm
Version Model NumberMM0017
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
GS105060188820734 [Unit of Use]
GS105060188820741 [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

Devices Manufactured by MANUKAMED LIMITED PARTNERSHIP

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00854056008011 - First Honey Sterile Honey Ointment (0.5 Oz)2020-05-22
00854056008035 - First Honey Manuka Bandages2020-05-22 A unit carton of 12 Bandages.
00854056008042 - First Honey Manuka Dressings2020-05-22 A unit carton of six 3" x4" Manuka Honey coated adhesive island wound dressings
00854056008134 - First Honey Sterile Honey Ointment (1.0 Oz)2020-05-22
05060188820055 - MANUKAhd Lite 5 x 5 cm2020-05-22
05060188820093 - MANUKAhd Lite 10 x 12.5 cm2020-05-22
05060188820222 - First Honey Manuka Bandages2020-05-22 A unit carton of twelve 1"x3" manuka honey coated bandages.

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