GEMCORE360 AM-WC-SHGEL45

GUDID 10610888002071

Silver Gel Tube 45g, flowerpot

ADVANCED MEDICAL SOLUTIONS LIMITED

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Primary Device ID10610888002071
NIH Device Record Key86ff5283-6148-4d2d-bd36-08c662cde2a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEMCORE360
Version Model NumberSilver Hydrogel
Catalog NumberAM-WC-SHGEL45
Company DUNS770434090
Company NameADVANCED MEDICAL SOLUTIONS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110610888002071 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-10-30
Device Publish Date2022-12-08

On-Brand Devices [GEMCORE360 ]

10610888002170Silicone PHMB Foam Border Dressings.
10610888002163Silicone PHMB Foam Border Dressing.
1061088800215641-24AP Silver HPD
1061088800214941-24AP Silver HPD
1061088800213241-24AP Silver HPD
10610888002064Hydrogel Tube 15g
10610888002057Hydrogel Tube 8g
10610888000398Hydrocolloid Foam Backed Dressing.
10610888000381Hydrocolloid Foam Backed Dressings
10610888000374Hydrocolloid Foam Backed Dressing.
10610888000367Hydrocolloid Film Backed Dressings.
10610888000350Hydrocolloid Film Backed Dressings
10610888000343Hydrocolloid Film Backed Dressing.
10610888000336PHMB Foam Non-Adhesive (Gamma)
10610888000329PHMB Foam Non-Adhesive (Gamma)
10610888000312PHMB Foam Adhesive
10610888000305PHMB Foam Adhesive
10610888000299Foam Lite Non Border
10610888000282Foam Lite Non Border
10610888000275Foam Lite Border
10610888000268Foam Lite Border
10610888000251Silicone Trilaminate Foam Non-Border
10610888000244Silicone Trilaminate Foam Non-Border
10610888000237Silicone Trilaminate Foam Non-Border
10610888000220Silicone Trilaminate Foam Border
10610888000213Silicone Trilaminate Foam Border
10610888000206Silicone Trilaminate Foam Border
1061088800019041-21AP
1061088800018341-21AP
1061088800017641-21AP
1061088800016914-24DP Silver Alginate IV
1061088800015214-24DP Silver Alginate IV
1061088800014514-24DP Silver Alginate IV
106108880001381-21DP Reinforced
106108880001211-21DP Reinforced
106108880001141-21DP Reinforced
10610888002071Silver Gel Tube 45g, flowerpot

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