FDA.reportPublic FDA data

NA

Primary DI
04251339900059
Brand
NA
Company
MAVIG GmbH
Model
STEA-OT5
Catalog number
STEA-OT5
Device description
Sterile disposable cover for OT50001/OT90001, 74 x 120 cm (1 pouch)
Published
2017-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MMPCover, Barrier, Protective

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251339900059PackageGS150In Commercial Distribution
04251339900066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251339900059042513399000594251339900059
04251339900066042513399000664251339900066

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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
10193489130225COLABELMEDLINE INDUSTRIES, INC.MMP2024-04-11
10884389413630Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
10884389413647Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
10884389614600Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
10195327422202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-06-04
10080196900701Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489469455Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489490497Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489771442Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489771466Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489771473Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489771480Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489771497Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10195327052584Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10195327057404Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10195327057657Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10195327057664Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10195327060084Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
M752SS1707870STRADISSTRADIS MEDICAL, LLCMMP2022-05-31
M75240290SCC0Stradis Medical, LLC.STRADIS MEDICAL, LLCMMP2022-05-27
M7521001NS0Stradis Medical, LLC.STRADIS MEDICAL, LLCMMP2022-04-26
10195327004224Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2021-10-03
10080196497591MedlineMEDLINE INDUSTRIES, INC.MMP2021-07-16
10884389028414MedlineMEDLINE INDUSTRIES, INC.MMP2021-02-11
10888277677975MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMP2021-01-29
10884389029510ACCUFITMEDLINE INDUSTRIES, INC.MMP2021-01-26
10080196073160MedlineMEDLINE INDUSTRIES, INC.MMP2020-12-31
10080196001804MedlineMEDLINE INDUSTRIES, INC.MMP2020-12-23
10884389001806MedlineMEDLINE INDUSTRIES, INC.MMP2020-12-23
10080196073191MedlineMEDLINE INDUSTRIES, INC.MMP2020-11-26