Intera Ap-04011

by Intera Oncology

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00850014110024 UDI-DI	Date23 Jun 2021Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Intera
Generic name: Hypodermic needle, single-use
Model / Ref / Catalog: AP-04011, AP04011

Primary DI / UDI-DI: 00850014110024
FDA product code: LKK, PTI
GMDN term: Hypodermic needle, single-use

Device class: Class III
Regulation number: 880.5570
GUDID distribution status: In Commercial Distribution

Size: Length — 1.5 Inch
Needle Gauge — 22 Gauge

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See all devices from Intera Oncology →

Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10)

Sterilise before use: No
Implantable: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Manufacturing date: No