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Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
Medline FDA UDI
Generic Name
Surgical dressing/drape kit, single-use FDA UDI
Device Name
DRAPE,INCISE,6.5"X7.5",INVISISHIELD FDA UDI
Model / Reference
DYNJSD1035 FDA UDI
Description
DRAPE,INCISE,6.5"X7.5",INVISISHIELD FDA UDI

Identifiers

Catalog Number
DYNJSD1035 FDA UDI
Primary DI / UDI-DI
10080196739424 FDA UDI
FDA Product Code
PUI FDA UDI
GMDN Term
Surgical dressing/drape kit, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 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

No

FDA UDI

Over-the-Counter

Yes

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

Category: Surgical dressing/drape kit, single-use

Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical dressing/drape kit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medline Industries, Inc.

Sources (1)

  • FDA UDI f2a36b4f-3f27-4105-a4ce-eb6f2465fd56 36 fields · synced May 30, 2026