FDA.reportPublic FDA data

NA

Primary DI
04251339900097
Brand
NA
Company
MAVIG GmbH
Model
STEA-WD261
Catalog number
STEA-WD261
Device description
Sterile disposable cover for WD261xx, 127 x 90 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
04251339900097PackageGS120In Commercial Distribution
04251339900103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251339900097042513399000974251339900097
04251339900103042513399001034251339900103

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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04251339900707UTUT6902-GE2023-07-12
04251339900714UTUT6904-GE2023-07-12
04251339900745UTE-UT61U30 2023-07-12
04251339900752UTE-UT61U40 2023-07-12
04251339900776UTE-UT69U020 2023-07-12
04251339900783UTE-UT59U020 2023-07-12
04251339900790UTE-UT60U050 2023-07-12
04251339900806UTE-UT60U008 2023-07-12
04251339900813UTE-UT69U025 2023-07-12
04251339900837UTE-UT68U020 2023-07-12
04251339903784UTUT61102023-07-12
04251339903791UTUT6110-SI2023-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814707023817ProtekASPEN SURGICAL PRODUCTS, INC.MMP2026-02-16
00850061871053IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMP2024-10-23
00850061871039IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMP2024-10-22
40193489130226COLABELMEDLINE INDUSTRIES, INC.MMP2024-04-11
40884389413631Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
40884389413648Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
40884389614601Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-10-01
40195327422203Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-06-04
10193489189223MedlineMEDLINE INDUSTRIES, INC.MMP2022-11-10
40080196900702Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489469456Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489490498Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771443Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771467Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771474Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771481Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40193489771498Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327052585Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327057405Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327057658Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327057665Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
40195327060085Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
M7521001NS1Stradis Medical, LLC.STRADIS MEDICAL, LLCMMP2022-04-26
10810050854174Typenex Extubation BibTYPENEX MEDICAL LLCMMP2022-04-04
00850977007881IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.MMP2021-12-14
40195327004409Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2021-10-03
10193489400625Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2021-07-04
40193489437127MedlineMEDLINE INDUSTRIES, INC.MMP2021-02-11
20888277677972MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMP2021-01-29
40080196073161MedlineMEDLINE INDUSTRIES, INC.MMP2020-12-31