SmartGuide Disposable Needle Guides and Grids FPRPR00013

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	Number07290016936308 UDI-DI	Date30 Aug 2026Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: SmartGuide Disposable Needle Guides and Grids
Generic Name: Needle guide, single-use
Model / Ref / Catalog: FPRPR00013

Primary DI / UDI-DI: 07290016936308
510(k) Number: K260161
FDA Product Code: ITX
GMDN Term: Needle guide, single-use

Device Class: Class II
Regulation Number: 892.1570
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Unsafe

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Properties

Sterile
Single Use
Prescription Use
Lot / Batch Number
Expiration Date

Other properties (9)

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