810-64

by Eagle Labs, LLC

810-64 is a Class II device made by Eagle Labs, LLC, listed in FDA GUDID since 28 Oct 2016 (UDI-DI 00810090014142), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00810090014142 UDI-DI	Date28 Oct 2016Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00810090014142

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic name: Ophthalmic surgical drape
Model / reference: 810-64

Primary DI / UDI-DI: 00810090014142
FDA product code: HMT
GMDN term: Ophthalmic surgical drape

Device class: Class II
Regulation number: 878.4370
GUDID distribution status: In Commercial Distribution

Sterilisation method: Ethylene Oxide

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Properties

Supplied sterile
Sterilise before use
Single use
Prescription use
Premarket exempt
Lot / batch number
Expiration date
Manufacturing date

Other properties (7, all answered No)