FDA.reportPublic FDA data

Medline-Microtek

Primary DI
20748426263602
Brand
Medline-Microtek
Company
Microtek Medical LLC
Model
Patient Drapes
Catalog number
4107N
Device description
Patient Drape, Epidural Drape, 102 cm x 81 cm with 7.6 cm Fenestration (40 in x 32 in with 3in Fenestration)
Published
2026-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20748426263602PrimaryGS10
00748426263608Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2074842626360220748426263602
00748426263608007484262636087484262636080748426263608

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
1-800-633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
106908437
Device count
200
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00748426263448Convertors®Equipment Drapes29-290092026-06-09
00748426121861OLYMPUSEquipment DrapesOME-V2-D2026-05-28
00748426146802Medline-MicrotekFluid Warming - Warmer EquipmentEFW5L2026-05-20
00748426146925Medline-MicrotekSurgical Slush - Hush-Slush EquipmentORS-1075EU2026-05-20
00748426146932Medline-MicrotekSurgical Slush - Hush-Slush EquipmentORS-2038EU2026-05-20
00748426262076AQUABLATION THERAPY®Patient DrapesDR39002026-04-06
00748426264483Medline-MicrotekPatient Drapes5960UK2026-03-16
00748426264490Medline-MicrotekEquipment Drapes8033651EU2026-03-16
00748426264506Medline-MicrotekEquipment Drapes49652026-03-16
20748426264487Medline-MicrotekPatient Drapes5960UK2026-03-16
20748426264494Medline-MicrotekEquipment Drapes8033651EU2026-03-16
10748426264503Medline-MicrotekEquipment Drapes49652026-03-16
00748426264315Medline-MicrotekPatient Drapes59602026-02-11
00748426261543NA33206633202026-02-26
10748426261540NA33206633202026-02-26
10748426144294Medline-MicrotekEquipment Drapes5096NS2026-02-18
10748426144560Medline-MicrotekEquipment Drapes15427-002026-02-18
10748426144584Medline-MicrotekEquipment Drapes2904N2026-02-18
10748426144591Medline-MicrotekEquipment Drapes4604N2026-02-18
10748426144607Medline-MicrotekEquipment Drapes4650N2026-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20193489029939MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
20193489029953MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
30193489028199MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
16931918102214AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918102948AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
16931918107356AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-07-16
20193489108214MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
20888277636559MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-13
00628110259554MolecuLightDX Eco DarkDrapes (Case of 50)MolecuLight IncPUI2026-07-08
00628110259578MolecuLightDX DarkDrape Eco ClipMolecuLight IncPUI2026-07-08
06932523052430Equipment DrapeJiangSu MedPlus Non-Woven Manufacturer Co., LtdPUI2026-07-08
10304040193362Henry ScheinHENRY SCHEIN, INC.PUI2026-06-25
00748426263448Convertors®Microtek Medical LLCPUI2026-06-09
30680651501272HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501289HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501296HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501302HalyardO&M HALYARD, INC.PUI2026-06-08
16931918100876AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918102450AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104201AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104416AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104645AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104843AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104935AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918105239AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918106977AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918107400AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918107929AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918108261AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109640AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04