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Sterile Drape

FDA UDI

Class I (US FDA UDI)

by Avinger, Inc.

Identity

Trade Name
Sterile Drape FDA UDI
Generic Name
Patient surgical drape, single-use FDA UDI
Device Name
The Sterile Drape is designed to function as a protective barrier between the sterile and non-sterile environments during surgical procedures FDA UDI
Model / Reference
SD100 FDA UDI
Description
The Sterile Drape is designed to function as a protective barrier between the sterile and non-sterile environments during surgical procedures FDA UDI

Identifiers

Catalog Number
SD100 FDA UDI
Primary DI / UDI-DI
00851354004264 FDA UDI
FDA Product Code
KKK FDA UDI
GMDN Term
Patient surgical drape, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.1850 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Patient surgical drape, single-use

Sterile Drape by Avinger, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient surgical drape, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avinger, Inc.

Sources (1)

  • FDA UDI aba2f708-cf54-414d-8081-9393bb6e1daa 35 fields · synced May 30, 2026