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FreeClimb 46 Catheter x125cm Gen 1

by Route 92 Medical, Inc.

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

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850085183002 UDI-DI Date12 Oct 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
FreeClimb 46 Catheter x125cm
Generic Name
Vascular guide-catheter, single-use
Model / Reference
Gen 1
Primary DI / UDI-DI
00850085183002
FDA Product Code
QJP
GMDN Term
Vascular guide-catheter, single-use
Device Class
Class II
Regulation Number
870.1250
GUDID distribution status
In Commercial Distribution
Size
Length — 143 Centimeter
Length — 125 Centimeter

Other devices from Route 92 Medical, Inc.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No