MANUKAhd SuperLite Rolls

GUDID 05060188821403

MANUKAMED LIMITED PARTNERSHIP

Exudate-absorbent dressing, non-gel, antimicrobial, sterile
Primary Device ID05060188821403
NIH Device Record Key374ea80d-7806-4e4b-960e-bb29ce2110fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameMANUKAhd SuperLite Rolls
Version Model NumberMM0074
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 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
GS105060188821397 [Unit of Use]
GS105060188821403 [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.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.