FDA.report

Medline-Microtek

Primary DI
00748426144563
Brand
Medline-Microtek
Company
Microtek Medical LLC
Model
Equipment Drapes
Catalog number
15427-00
Device description
LIGHT HANDLE COVER-LARGE
Published
2026-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FTALight, Surgical, Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
FTALight, Surgical, AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10748426144560PrimaryGS10
00748426144563Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1074842614456010748426144560
00748426144563007484261445637484261445630748426144563

GMDN Terms

TermDefinition
Medical equipment handle cover, single-useA device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
1(800)633-5463customerservice@medline.com

Regulatory Flags

DUNS number
106908437
Device count
200
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

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20748426264487Medline-MicrotekPatient Drapes5960UK2026-03-16
20748426264494Medline-MicrotekEquipment Drapes8033651EU2026-03-16
10748426264503Medline-MicrotekEquipment Drapes49652026-03-16
00748426264315Medline-MicrotekPatient Drapes59602026-02-11
10748426261540NA33206633202026-02-26
10748426144577Medline-MicrotekEquipment Drapes2222505H2026-02-18
10748426144638Medline-MicrotekEquipment Drapes61515RT2026-02-18
10748426144645Medline-MicrotekEquipment Drapes8838M2026-02-18
10748426144690Medline-MicrotekEquipment Drapes9951-202026-02-18
10748426144737Medline-MicrotekEquipment Drapes8900102026-02-18
10748426144744Medline-MicrotekEquipment Drapes8900162026-02-18
10748426144751Medline-MicrotekEquipment Drapes8900172026-02-18
10748426145468Medline-MicrotekEquipment Drapes99042026-02-18
10748426145475Medline-MicrotekEquipment Drapes99072026-02-18
10748426145505Medline-MicrotekEquipment Drapes29042026-02-18
10748426145512Medline-MicrotekEquipment Drapes46042026-02-18
10748426145529Medline-MicrotekEquipment Drapes46242026-02-18
10748426145536Medline-MicrotekEquipment Drapes49542026-02-18
10748426145543Medline-MicrotekEquipment Drapes49732026-02-18
10748426145550Medline-MicrotekEquipment Drapes59002026-02-18

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