← Back to catalogue

Austin

FDA UDI

Class II (US FDA UDI)

by Austin Medical, Inc.

Identity

Trade Name
Austin FDA UDI
Generic Name
Instrument/equipment drape, single-use, sterile FDA UDI
Device Name
Total Capture Hysteroscopy Drape FDA UDI
Model / Reference
Au-10-143S FDA UDI
Description
Total Capture Hysteroscopy Drape FDA UDI

Identifiers

Catalog Number
Au-10-143S FDA UDI
Primary DI / UDI-DI
00866001000339 FDA UDI
510(k) Number
K061422 FDA UDI
FDA Product Code
KKX FDA UDI
GMDN Term
Instrument/equipment drape, single-use, sterile 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

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Instrument/equipment drape, single-use, sterile

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

Similar devices

Also classified as Instrument/equipment drape, single-use, sterile.

Cleared under the same submission

K061422 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Austin Medical, Inc.

Sources (1)

  • FDA UDI 1d74285e-e023-4e05-925b-ba686b23db4a 35 fields · synced May 30, 2026