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Device Explorer · FDA GUDID · GMDN 46801

Subcutaneous tunneller, single-use

A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is availa

US‑registered devices171in commercial distribution
Companies26labelers on GUDID
Single‑use87%of device records
Sterile88%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Avanos Medical, Inc.5834%
Nalu Medical, Inc.1911%
Medtronic, Inc.169%
Integra Lifesciences Production Corporation95%
Aesculap Ag85%
Medtronic Ps Medical, Inc.85%
Natus Medical Incorporated85%
Medical Components, Inc.74%

Top labelers

CompanyDevicesShare
Avanos Medical, Inc.5834%
Nalu Medical, Inc.1911%
Medtronic, Inc.169%
Integra Lifesciences Production Corporation95%
Aesculap Ag85%
Medtronic Ps Medical, Inc.85%
Natus Medical Incorporated85%
Medical Components, Inc.74%
Sophysa53%
Ethicon Endo-Surgery, Llc53%
Raumedic Ag42%
Medionics International Inc42%

Company = labeler of record on GUDID. 26 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Mainstay TunnelerTunneling KIT CH12Spliceable Tunneling Sleeve CH12Tunneling KIT CH8Spliceable Tunneling Sleeve CH8TunnEler 235AESCULAPBIOTRONIKTunneler LSophysaN/AN/ANANAN/AambITNalu Medical, Inc.Prometra Tunneler

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
GYKInstrument, shunt system implantation31
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)20
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)19
HAOINSTRUMENT, SURGICAL, NON-POWERED18
KNTTubes, gastrointestinal (and accessories)17
MEBPUMP, INFUSION, ELASTOMERIC17

GMDN & GCC registration

  • GMDN code 46801 · non‑implantable
  • Single‑use 87% · sterile 88% · Rx‑only 83% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Centimeter) · 20Length (Inch) · 8Needle Gauge (Gauge) · 5Catheter Gauge (French) · 5Length (Millimeter) · 1Outer Diameter (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

How many subcutaneous tunneller, single-use products are registered in the US?

171 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Subcutaneous tunneller, single-use", from 26 companies. The largest labeler is Avanos Medical, Inc. with 34% of records.

Which FDA product codes apply?

GYK (Instrument, shunt system implantation), GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief)), GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)), HAO (INSTRUMENT, SURGICAL, NON-POWERED)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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