FDA.reportPublic FDA data

SURGICAL STERILE DRAPE

Primary DI
08056646502004
Brand
SURGICAL STERILE DRAPE
Company
OMNIA SRL
Model
22.T1783.00
Device description
LIQUID REPELLENT DRAPE CM 133X200 WITH TRIANGLE HOLE CM 11X10 AND TRANSPARENT OPENING - SONTARA - BLUE
Published
2016-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KKXDrape, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056646502004PrimaryGS10
08056646501991Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056646502004080566465020048056646502004
08056646501991080566465019918056646501991

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390524527453info@omniaspa.eu

Regulatory Flags#

DUNS number
447696675
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052141311806Irrigation Line32.F0139.002026-03-27
08052141312025Irrigation Line32.F0170.002026-03-27
08052141312780Irrigation Line32.F0006.002026-03-27
08052141312865Irrigation Line32.F0134.002026-03-27
08052141312940Irrigation Line32.F0161.002026-03-27
08052141313602Irrigation Line32.F0105.002026-03-27
08056646500291Basic Implant Set12.S5621.002026-03-27
08056646500307Implantology Set12.S4671.002026-03-27
08056646500321Oral Surgery Set12.S4096.002026-03-27
08056646500482Oral Surgery Pack12.S8318.00 2026-03-27
08056646508846Adhesive Films32.U0020.002026-03-27
08056646508945Adhesive Films32.U4020.002026-03-27
08056646503018Sterile PTFE Surgical Suture32.Z4400.002017-02-27
08056646500017Sterile PTFE Surgical Suture32.Z3130.002016-05-31
08056646500031Sterile PTFE Surgical Suture32.Z3141.002016-07-07
08056646500055Sterile PTFE Surgical Suture32.Z3150.002016-08-29
08056646500079Sterile PTFE Surgical Suture32.Z3160.002016-08-29
08056646500086Sterile PTFE Surgical Suture32.Z3151.002016-08-29
08056646500116Sterile PTFE Surgical Suture32.Z3260.002016-08-29
08056646500123Sterile PTFE Surgical Suture32.Z3240.002016-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056646500291Basic Implant SetOMNIA SRLKKX2026-03-27
08056646500307Implantology SetOMNIA SRLKKX2026-03-27
08056646500321Oral Surgery SetOMNIA SRLKKX2026-03-27
08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10080196176700Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496648Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496655Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496686Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497171Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497188Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497195Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497720Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497744Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498239Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498673Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498772Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196025893MEDLINEMEDLINE INDUSTRIES, INC.KKX2022-10-03
10080196496563Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2022-03-20
10080196496662Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2022-03-20
10080196497713Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2022-03-20
10080196007134MedlineMEDLINE INDUSTRIES, INC.KKX2021-09-22
10080196311033MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KKX2021-03-16
10080196325825MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KKX2021-03-16
10080196333950MedlineMEDLINE INDUSTRIES, INC.KKX2021-03-16
10080196571932MedlineMEDLINE INDUSTRIES, INC.KKX2021-01-26
10080196744213MedlineMEDLINE INDUSTRIES, INC.KKX2020-11-11
10080196748150MedlineMEDLINE INDUSTRIES, INC.KKX2020-11-10
10080196747115MedlineMEDLINE INDUSTRIES, INC.KKX2020-11-09