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Incise Film

FDA UDI

Class I (US FDA UDI)

by Hurricane Medical

Identity

Trade Name
Incise Film FDA UDI
Generic Name
Hypoallergenic skin adhesive tape FDA UDI
Device Name
Cover lashes, lids, and brow for ophthalmic surgery, or office procedures. Adhesive area 12.7 x 18.4 cm. FDA UDI
Model / Reference
9701 FDA UDI
Description
Cover lashes, lids, and brow for ophthalmic surgery, or office procedures. Adhesive area 12.7 x 18.4 cm. FDA UDI

Identifiers

Catalog Number
9701 FDA UDI
Primary DI / UDI-DI
00813465012194 FDA UDI
FDA Product Code
KGX FDA UDI
GMDN Term
Hypoallergenic skin adhesive tape FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5240 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 22.8 Centimeter FDA UDI
Width — 12.7 Centimeter FDA UDI

Category: Hypoallergenic skin adhesive tape

Incise Film by Hurricane Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hypoallergenic skin adhesive tape.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hurricane Medical

Sources (1)

  • FDA UDI 79b1c7d8-174c-4a1a-8218-6868ad637208 35 fields · synced May 30, 2026