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Cer-Ext 11 Ga X 6.4 Cm

by Ranfac Corp.

Cer-Ext 11 Ga X 6.4 Cm is a Class II device made by Ranfac Corp., cleared under FDA 510(k) K150563 on 22 May 2015 and listed in FDA GUDID since 9 Nov 2021 (UDI-DI 00850023741448), active as of 22 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 22 Oct 2026

Documents

510(k) K150563

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850023741448 UDI-DI Date9 Nov 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150563 Date22 May 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150563 decided 22 May 2015 Active
  • FDA GUDID UDI-DI 00850023741448 listed 9 Nov 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K150563
  2. Listed FDA GUDID 00850023741448

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cer-Ext
Generic name
Bone access cannula
Model / Ref / Catalog
11 GA X 6.4 CM, CER-EXT
Description
CER-EXT NEEDLE, F/G, STERILE, CE PN: 74395-01M
Primary DI / UDI-DI
00850023741448
510(k) Number
FDA product code
KNW
GMDN term
Bone access cannula
Device class
Class II
Regulation number
876.1075
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 11 Gauge
Length — 6.4 Centimeter

Related devices

Category: Bone access cannula

Cleared under the same submission (K150563)

and 8 more cleared under K150563

Similar devices

Other devices filed under FDA product code KNW (Instrument, Biopsy).

Other devices from Ranfac Corp.

See all devices from Ranfac Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)