Device Explorer · FDA GUDID · GMDN 10667

Cast boot

A boot-like device designed to be attached around a leg cast to protect and support the cast, and to assist with patient mobility. This device is generally equipped with a waterproof covering, an outer sole for walking, and closures for easy application and re

US‑registered devices147in commercial distribution
Companies7labelers on GUDID
Single‑use54%of device records
Sterile0%labelled sterile
Prescription9%Rx‑only share
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Share of device records

Darco International, Inc.5034%
Manamed, Inc.4128%
Acell, Inc.3322%
Unite Medical, Llc107%
Md Orthopaedics, Inc.85%
Medline Industries, Inc.32%
Drive Devilbiss Healthcare21%

Top labelers

CompanyDevicesShare
Darco International, Inc.5034%
Manamed, Inc.4128%
Acell, Inc.3322%
Unite Medical, Llc107%
Md Orthopaedics, Inc.85%
Medline Industries, Inc.32%
Drive Devilbiss Healthcare21%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ManaMedUnite Medical®DriveFlexSafe Ankle Recovery Orthosis, Extra SmallFlexSafe Ankle Recovery Orthosis, Extra LargeFlexSafe Ankle Recovery Orthosis, SmallFlexSafe Ankle Recovery Orthosis, MediumFlexSafe Ankle Recovery Orthosis, LargeRhinoMedE-Kast®TCC-EZ®DARCO® Body Armor® Cast ShoeDARCO® SlimLine™ cast bootDARCO® SlimLine™ PediatricDARCO® Cast Boot PediatricCast boot, canvas

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

FDA product codes

CodeNameDevices
ITWJoint, Ankle, External Brace51
IPGSHOE, CAST50
ITGBANDAGE, CAST37
IPGShoe, Cast18
FSMTRAY, SURGICAL, INSTRUMENT3
KIACOVER, CAST2

GMDN & GCC registration

  • GMDN code 10667 · non‑implantable
  • Single‑use 54% · sterile 0% · Rx‑only 9% · OTC 40%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

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

How many cast boot products are registered in the US?

147 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cast boot", from 7 companies. The largest labeler is Darco International, Inc. with 34% of records.

Which FDA product codes apply?

ITW (Joint, Ankle, External Brace), IPG (SHOE, CAST), ITG (BANDAGE, CAST), IPG (Shoe, Cast)

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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