Sterile Equipment Cover 07-PK822

by Advance Medical Designs, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00848340012686 UDI-DI	Date27 Feb 2024Listed	StatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

- Terminated Z-1036-04 FDA Unclassified (pre-2012) initiated 18 Jun 2004
The product may come apart when excessive force is applied to the coupler.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Sterile Equipment Cover
Generic Name: Medical equipment/instrument drape, single-use
Model / Reference: 07-PK822

Primary DI / UDI-DI: 00848340012686
510(k) Number: K850959
FDA Product Code: JAA
GMDN Term: Medical equipment/instrument drape, single-use

Device Class: Class II
Regulation Number: 892.1650
GUDID distribution status: In Commercial Distribution

Sterilization Method: Ethylene Oxide

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Properties

Single Use
Lot / Batch Number
Expiration Date

Other properties (11)

Sterile: No
Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Manufacturing Date: No