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Device Explorer · FDA GUDID · GMDN 16462

Surgical countersink, reusable

A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The

US‑registered devices692in commercial distribution
Companies67labelers on GUDID
Single‑use10%of device records
Sterile8%labelled sterile
Prescription90%Rx‑only share
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Share of device records

Tyber Medical, Llc548%
Dentis Co. ,Ltd375%
Wright Medical Technology, Inc.365%
Synthes Gmbh335%
Southern Implants (Pty) Ltd325%
Biomet Orthopedics, Llc304%
Vilex In Tennessee, Inc.284%
Paragon 28, Inc.274%

Top labelers

CompanyDevicesShare
Tyber Medical, Llc548%
Dentis Co. ,Ltd375%
Wright Medical Technology, Inc.365%
Synthes Gmbh335%
Southern Implants (Pty) Ltd325%
Biomet Orthopedics, Llc304%
Vilex In Tennessee, Inc.284%
Paragon 28, Inc.274%
Newclip Technics233%
Tornier, Inc.233%
Trimed, Inc.223%
Stryker Gmbh203%

Company = labeler of record on GUDID. 67 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAVARIAXASNISFIXOSMISPiccolo Composite Plate SystemCOUNTERSINK DRILLDitron DentalCountersink DrillCountersink 2.4Countersink 1.5Countersink 1.3Countersink, CannulatedInion FreedomScrew instrumentsInion® Universal instrumentsActiva Instrument

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

FDA product codes

CodeNameDevices
HWWCOUNTERSINK183
HWWCountersink154
NDPAccessories, Implant, Dental, Endosseous76
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT73
HWCScrew, fixation, bone44
LXHOrthopedic manual surgical instrument28

GMDN & GCC registration

  • GMDN code 16462 · non‑implantable
  • Single‑use 10% · sterile 8% · Rx‑only 90% · 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

Outer Diameter (Millimeter) · 15Length (Millimeter) · 4Outer Diameter (Inch) · 2Length (Centimeter) · 1

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

How many surgical countersink, reusable products are registered in the US?

692 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical countersink, reusable", from 67 companies. The largest labeler is Tyber Medical, Llc with 8% of records.

Which FDA product codes apply?

HWW (COUNTERSINK), HWW (Countersink), NDP (Accessories, Implant, Dental, Endosseous), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT)

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.

How do I get quotes?

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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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