Precision Tunneler - Small 41.020.501

by Arkis Biosciences Inc.

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00866614000153 UDI-DI	Date13 Dec 2018Listed	StatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Precision Tunneler - Small
Generic Name: Subcutaneous tunneller, single-use
Model / Ref / Catalog: 41.020.501

Primary DI / UDI-DI: 00866614000153
FDA Product Code: GYK
GMDN Term: Subcutaneous tunneller, single-use

Device Class: Class I
Regulation Number: 882.4545
GUDID distribution status: Not in Commercial Distribution

MRI Safety: MR Unsafe

Other devices from Arkis Biosciences Inc.

SureFlo EVD Catheter Open recall

Class II

Properties

Sterile
Single Use
Prescription Use
Premarket Exempt
Lot / Batch Number
Expiration Date

Other properties (8)

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