FDA.reportPublic FDA data

MICROTEK

Primary DI
00748426003808
Brand
MICROTEK
Company
Microtek Medical LLC
Model
1
Device description
PATIENT ISOLATION DRAPE, LATEX FREE, 1-EACH
Published
2016-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
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
50748426003803PackageGS110In Commercial Distribution
00748426003808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074842600380350748426003803
00748426003808007484260038087484260038080748426003808

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store under normal warehouse conditions.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)824-3027customerservicemicrotekmed.com@ecolab.com

Regulatory Flags#

DUNS number
106908437
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
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
16931918109855AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109879AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918117102AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04