ManukaPli 44ge

GUDID 05060188822387

MANUKAMED LIMITED PARTNERSHIP

Medical-honey liquid barrier dressing, sterile
Primary Device ID05060188822387
NIH Device Record Keyae4c5e0a-6a88-4918-9a11-1cda39b98805
Commercial Distribution StatusIn Commercial Distribution
Brand NameManukaPli 44ge
Version Model NumberMM0051
Company DUNS594970245
Company NameMANUKAMED LIMITED PARTNERSHIP
Device Count1
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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060188822387 [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 Date2019-06-03
Device Publish Date2019-05-24

Devices Manufactured by MANUKAMED LIMITED PARTNERSHIP

00854056008004 - First Honey Sterile Honey Ointment (1.0 Oz)2020-05-22
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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