P&P needle guide sleeve 12G (disposable) 01

by NORAS MRI products GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

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	Number04251269201837 UDI-DI	Date11 Aug 2017Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: P&P needle guide sleeve 12G (disposable)
Generic Name: MRI system coil, radio-frequency
Model / Ref / Catalog: 01, 112653

Primary DI / UDI-DI: 04251269201837
510(k) Number: K081118
K082373
FDA Product Code: MOS
GMDN Term: MRI system coil, radio-frequency

Device Class: Class II
Regulation Number: 892.1000
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Safe

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Properties

Sterile
Single Use
Lot / Batch Number

Other properties (11)

Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No