FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10080196810031
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
SA-DRPSPLTSHT
Catalog number
SA-DRPSPLTSHT
Device description
DRAPE-SPLIT SHEET
Published
2016-11-07
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
FDElaparoscopy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDELaparoscopy KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196810032PackageGS124In Commercial Distribution
10080196810031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019681003240080196810032
1008019681003110080196810031

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 or an adhesive film sheet otherwise known as an incise drape). 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
Premarket exempt
true
Lot or batch
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
10198956515871CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10198956524354CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10198956530805CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10198956534421CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10198956538573CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10809160527931HALYARDAVID MEDICAL, INC.FDE2026-07-28
10198956218109CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956360457CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956378339CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956429949CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956460652CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956462991CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956512351CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956516830CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956519619CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956523296CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956528710CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956533332CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
B098AMS187280Aligned Medical SolutionsAligned Medical SolutionsFDE2026-07-22
10198956388888CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956494701CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956515680CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956516939CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956521681CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956532588CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956458987CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-16
10198956513099CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-16
10198956528499CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-16
10198956531239CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-16
B098AMS184440Aligned Medical SolutionsAligned Medical SolutionsFDE2026-07-12