FDA.reportPublic FDA data

Full body incise drape wetlaid 140 x 244cm

Primary DI
05060647232221
Brand
Full body incise drape wetlaid 140 x 244cm
Company
NULINE LIMITED
Model
60300558
Device description
A single use drape with pressure sensitive adhesive used to provide a barrier between the sterile surgical field and possible sources of microbes.
Published
2026-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
HMTDrape, Patient, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMTDrape, Patient, OphthalmicGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060647232221PrimaryGS10
15060647232228Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060647232221050606472322215060647232221
1506064723222815060647232228

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical drapeA protective covering made of natural or synthetic materials, or both, designed to promote a clean and dry sterile field about the eye during ophthalmic surgery or refractive and general ophthalmic office procedures. The device may be used to cover the eyebrow, retract lashes or eyelids, completely occlude the eyelid, or completely cover the eye. The device is typically secured directly to the skin with a pressure-sensitive adhesive, and is typically supplied sterile. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
223405915
Device count
60
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060647232177Medium half body incise drape wetlaid 127x140cm603002732026-10-06
05060647232184Medium half body apeture drape wetlaid 127 x 140cm603005532026-10-06
05060647232191Small half body aperture drape wetlaid 100x127cm603005552026-10-06
05060647232207Small half body incise drape wetlaid 100x127cm603005562026-10-06
05060647232214Full body aperture drape wetlaid 140 x 244cm603005572026-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060647232177Medium half body incise drape wetlaid 127x140cmNULINE LIMITEDHMT2026-10-06
05060647232184Medium half body apeture drape wetlaid 127 x 140cmNULINE LIMITEDHMT2026-10-06
05060647232191Small half body aperture drape wetlaid 100x127cmNULINE LIMITEDHMT2026-10-06
05060647232207Small half body incise drape wetlaid 100x127cmNULINE LIMITEDHMT2026-10-06
05060647232214Full body aperture drape wetlaid 140 x 244cmNULINE LIMITEDHMT2026-10-06
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