Consulting Wallah › Device Explorer › Other devices › Biopsy drill bit
Device Explorer · FDA GUDID · GMDN 11330

Biopsy drill bit

A shaft of metal designed to excise (cut out) a small section of bone or cartilage for microscopic examination. It is mounted into a surgical drilling device, either manual or powered, and when rotated at an appropriate speed will perform the required operatio

US‑registered devices105in commercial distribution
Companies13labelers on GUDID
Single‑use66%of device records
Sterile17%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Astura Medical4341%
Biomet Orthopedics, Llc2322%
Ambler Surgical Corp.1110%
Avalign Technologies, Inc.88%
Novo Surgical, Inc.66%
Synthes Gmbh44%
Izi Medical Products, Llc22%
Spineology Inc.22%

Top labelers

CompanyDevicesShare
Astura Medical4341%
Biomet Orthopedics, Llc2322%
Ambler Surgical Corp.1110%
Avalign Technologies, Inc.88%
Novo Surgical, Inc.66%
Synthes Gmbh44%
Izi Medical Products, Llc22%
Spineology Inc.22%
Medline Industries, Inc.22%
Stryker Leibinger Gmbh & Co. Kg11%
Aspen Surgical Products, Inc.11%
Princeton Medical Group, Inc.11%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NATWIST DRILLCROSS LOCKING DRILL BUSHING2.7MM STEPPED DRILLCALIBRATED DRILL 4.3MM X 333MM2.8MM X 150MM DRILL2.0MM X 150MM DRILL3.2MM DRILL BIT 280MMSymmetry Hudson4.3MM AO DRILL BIT (5.5 SCREW)3.2MM AO DRILL BIT (4.5 SCREW)RECONSTRUCTIVE DRILL BUSHINGWORKING CANNULA DRILL INSERTCANNULATED 2.7MM AO DRILLINTERLOCKING DRILL BUSHINGCALIBRATED DRILL 6.2MM X 483MM

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

FDA product codes

CodeNameDevices
HTWBIT, DRILL34
NKGPosterior Cervical Screw System21
KWPAppliance, Fixation, Spinal Interlaminal21
OVDIntervertebral Fusion Device With Integrated Fixation, Lumba18
MAXIntervertebral Fusion Device With Bone Graft, Lumbar18
KWQAppliance, Fixation, Spinal Intervertebral Body18

GMDN & GCC registration

  • GMDN code 11330 · non‑implantable
  • Single‑use 66% · sterile 17% · Rx‑only 97% · 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 (Millimeter) · 12Lumen/Inner Diameter (Millimeter) · 10Width (Millimeter) · 8Outer Diameter (Millimeter) · 3Depth (Millimeter) · 1Length (Inch) · 1

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

How many biopsy drill bit products are registered in the US?

105 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Biopsy drill bit", from 13 companies. The largest labeler is Astura Medical with 41% of records.

Which FDA product codes apply?

HTW (BIT, DRILL), NKG (Posterior Cervical Screw System), KWP (Appliance, Fixation, Spinal Interlaminal), OVD (Intervertebral Fusion Device With Integrated Fixation, Lumba)

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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