Double Lancet 1.0mm Wide Blade Only Ae-8106

by Katena Products, Inc.

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

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00841668141083 UDI-DI	Date7 Dec 2022Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Double Lancet 1.0mm Wide Blade Only
Generic Name: Ophthalmic knife, reusable
Model / Ref / Catalog: AE-8106

Primary DI / UDI-DI: 00841668141083
FDA Product Code: HNN
GMDN Term: Ophthalmic knife, reusable

Device Class: Class I
Regulation Number: 886.4350
GUDID distribution status: In Commercial Distribution

Other devices from Katena Products, Inc.

Glaukos HF5

Class I
Katena K20-6000

Class I
Katena K30-1445

Class II
Katena K3-9259

Class I
Katena K3-9258

Class I
Katena K3-9261

Class I

See all devices from Katena Products, Inc. →

Properties

Prescription Use
Premarket Exempt

Other properties (12)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Lot / Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No