Hdc Dlm-3134

Hdc Dlm-3134 is a Class I device made by Hdc Corp., cleared under FDA 510(k) K091390 on 30 Jul 2009 and listed in FDA GUDID since 23 Jun 2023 (UDI-DI 08057013140102), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08057013140102 UDI-DI	Date23 Jun 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK091390	Date30 Jul 2009Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08057013140102
FDA 510(k) database 510(k) number K091390

Across registries

2 registries list this device

FDA 510(k) K091390 decided 30 Jul 2009 Active
FDA GUDID UDI-DI 08057013140102 listed 23 Jun 2023 Listed

Timeline

2 dated events

30 Jul 2009 Cleared FDA 510(k) K091390
23 Jun 2023 Listed FDA GUDID 08057013140102

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Hdc
Generic name: Surgical screwdriver, reusable
Model / Ref / Catalog: DLM-3134

Primary DI / UDI-DI: 08057013140102
510(k) Number: K091390
FDA product code: LRZ
GMDN term: Surgical screwdriver, reusable

Device class: Class I
Regulation number: 878.4800
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under Surgical screwdriver, reusable.

Other devices from Hdc Corp.

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Properties

Sterilise before use
Lot / batch number

Other properties (13, all answered No)