Medical grade adhesive tapes 10x5 cm for fixing sheaths and drapes

GUDID 08056646508686

Medical grade adhesive tapes 10x5 cm for fixing sheaths and drapes

OMNIA SRL

Medical equipment drape, single-use
Primary Device ID08056646508686
NIH Device Record Keyc14e13df-c6ec-4242-86de-ff0afcd06a99
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedical grade adhesive tapes 10x5 cm for fixing sheaths and drapes
Version Model Number12.U0014.00
Company DUNS447696675
Company NameOMNIA SRL
Device Count50
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
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
GS108056646508679 [Primary]
GS108056646508686 [Unit of Use]

FDA Product Code

KGTDrape, Adhesive, Aerosol

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-06
Device Publish Date2023-06-28

Devices Manufactured by OMNIA SRL

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08056646500031 - Sterile PTFE Surgical Suture2025-04-22 PTFE Suture 75 cm - 4/0 - 16 mm 3/8 Needle - Body Reverse Cutting
08056646500055 - Sterile PTFE Surgical Suture2025-04-22 PTFE Suture 75 cm - 5/0 - 12 mm 1/2 Needle - Body Reverse Cutting
08056646500079 - Sterile PTFE Surgical Suture2025-04-22 PTFE Suture 75 cm - 6/0 - 11 mm 1/2 Needle - Body Reverse Cutting
08056646500086 - Sterile PTFE Surgical Suture2025-04-22 PTFE Suture 75 cm - 5/0 -12 mm Needle 3/8 - Body Reverse Cutting
08056646500116 - Sterile PTFE Surgical Suture2025-04-22 PTFE Suture 75 cm - 6/0 - Diamond tip 10 mm Needle 1/2 - Round Body
08056646500123 - Sterile PTFE Surgical Suture2025-04-22 PTFE Suture 75 cm - 4/0 - Diamond tip 18 mm Needle 3/8 - Round Body
08056646500154 - Sterile PTFE Surgical Suture2025-04-22 PTFE Suture 75 cm - 5/0 - Diamond tip 18 mm Needle 3/8 - Round Body

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