FDA.reportPublic FDA data

Medline

Primary DI
10080196529841
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJE4400XLR
Catalog number
DYNJE4400XLR
Device description
DRAPE, C-ARM, BANDS, 41X120
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
10080196529841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1008019652984110080196529841

GMDN Terms#

Term, Definition table
TermDefinition
C-arm drapeA sterile device intended to cover/wrap the C-arm and/or mini C-arm of a mobile or stationary fluoroscopic x-ray system and function as a physical barrier to prevent cross-contamination between the C-arm and the surgical staff/field during a procedure. It is typically made of flexible plastic and shaped to fit the C-arm; it is available in various sizes. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888277417205MEDLINEMSG9460MSG94602026-08-03
10888277417212MEDLINEMSG9465MSG94652026-08-03
10888277417229MEDLINEMSG9470MSG94702026-08-03
10888277417236MEDLINEMSG9475MSG94752026-08-03
10888277417243MEDLINEMSG9480MSG94802026-08-03
10888277417250MEDLINEMSG9485MSG94852026-08-03
10888277417267MEDLINEMSG9490MSG94902026-08-03
10888277603516MEDLINEMSG9590MSG95902026-08-03
20197344102898GeminiGEM3120CGEM3120C2024-08-02
20197344102904GeminiGEM3120SCGEM3120SC2024-07-15
10080196184125GeminiGEM3120SGEM3120S2016-10-14
10080196184286MEDLINEGEM3130SGEM3130S2016-10-14
10197344169405MEDLINEMSCSRG9636MSCSRG96362026-07-31
10198459678653MEDLINEURO175806PSURO175806PS2026-07-31
10198459678660MEDLINEURO175808PSURO175808PS2026-07-31
10198459678677MEDLINEURO175806SURO175806S2026-07-31
10198459678684MEDLINEURO175808SURO175808S2026-07-31
10198459678691MEDLINEURO175810SURO175810S2026-07-31
10198459679025MEDLINEURO175810PSURO175810PS2026-07-31
20197344219237MEDLINENON27393NON273932026-07-31

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