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HYDRACELL-EXT-5 11 Gauge x 6.3 CM 5cc

by Ranfac Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850075308040 UDI-DI Date25 Sep 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Hydracell-Ext-5
Generic Name
Bone access cannula
Model / Ref / Catalog
11 Gauge x 6.3 CM 5cc, HYDRA-EXT-5
Primary DI / UDI-DI
00850075308040
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 — 6.3 Centimeter

Related devices

Cleared under the same submission (K150563)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Combination Product
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No