FDA.reportPublic FDA data

NA

Primary DI
04251339900127
Brand
NA
Company
MAVIG GmbH
Model
STEA-FSAM
Catalog number
STEA-FSAM
Device description
Sterile disposable cover for femoral drape with 1 cutout (1 pouch)
Published
2017-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KKXDrape, Surgical
MMPCover, Barrier, Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2
MMPCover, Barrier, ProtectiveGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251339900110PackageGS150In Commercial Distribution
04251339900127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251339900110042513399001104251339900110
04251339900127042513399001274251339900127

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/equipment drape, single-use, sterileA sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317502326
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251339907669OTOT0294-EMC2026-04-14
04251339901520WDWD260/100/120E2026-02-12
04251339906082WDWD204-05172026-02-12
04251339906815UTUT70-10WS-PH2026-02-12
04251339906822OTOT5500292026-02-12
04251339907263OTOT5100252026-02-12
04251339907270OTOT5000892026-02-12
04251339907287OTOT5400342026-02-12
04251339907294OTOT580012026-02-12
04251339907393UTE-UT60U0642026-02-12
04251339907409OTE-OT54B01V50S2026-02-12
04251339906242RPRP6435M22SB12-PH2024-06-03
04251339906259RPRP6435L22SB12-PH2024-06-03
04251339906266RPRP6435X22SB12-PH2024-06-03
04251339906273RPRP6435S22SB12-PH2024-06-03
04251339906280OTOT54001I-MQ2024-06-03
04251339906297OTOT50001I-MQ2024-06-03
04251339906006OTPTZTS2002OT812024-04-19
04251339906013OTPTZTS2005OT812024-04-19
04251339900370WDWD26105 2023-07-13

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
10080196497591MedlineMEDLINE INDUSTRIES, INC.MMP2021-07-16
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
10080196073160MedlineMEDLINE INDUSTRIES, INC.MMP2020-12-31
10080196001804MedlineMEDLINE INDUSTRIES, INC.MMP2020-12-23