Adhesive film

GUDID 08056646503902

STERILE PROTECT. FILM (10/pkg) - Bien Air

OMNIA SRL

Medical equipment drape, single-use
Primary Device ID08056646503902
NIH Device Record Keyc9dad192-a498-4a15-9219-c0f2d1b8efca
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdhesive film
Version Model Number32.U0026.00
Company DUNS447696675
Company NameOMNIA SRL
Device Count10
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108056646503902 [Unit of Use]
GS108056646503919 [Primary]

FDA Product Code

FXTFilm, Camera, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-26
Device Publish Date2021-02-18

Devices Manufactured by OMNIA SRL

08056646509966 - Irrigation Set2024-11-19
08056646509980 - Irrigation Set2024-11-19
08052141311400 - Irrigation line, Kavo2023-08-16 Sterilizable Hose Set S600
08052141311424 - Irrigation line, Kavo2023-08-16 Hose set for Kavo INTRASurg (10/pkg)
08052141310014 - Transparent bag 67x75 cm with sliding ties for physiodispensers or for control u2023-07-06 Transparent bag 67x75 cm with sliding ties for physiodispensers or for control units
08056646505739 - Omnicover2023-07-06 Round waterproof headrest cover Ø 22 cm with elastic Shell Cover
08056646505890 - Universal seat cover and backrest cover Shell Cover2023-07-06 Universal seat cover and backrest cover Shell Cover
08056646508563 - Transparent drape 40x50 cm with adhesive tape for physiodispensers or for contro2023-07-06 Transparent drape 40x50 cm with adhesive tape for physiodispensers or for control units

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