Consulting Wallah › Device Explorer › Orthopaedic implants › Intestinal ostomy base plate, flat
Device Explorer · FDA GUDID · GMDN 48159

Intestinal ostomy base plate, flat

A non-sterile device designed with a flat surface intended to be applied and adhered to peristomal skin (typically of a normal, well-formed stoma) to facilitate the correct positioning and anchorage of the flange of an intestinal ostomy bag (i.e., one-piece or

US‑registered devices342in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Convatec, Purchasing Department11835%
Coloplast A/S8926%
Hollister Incorporated7422%
Safe N' Simple Llc6118%

Top labelers

CompanyDevicesShare
Convatec, Purchasing Department11835%
Coloplast A/S8926%
Hollister Incorporated7422%
Safe N' Simple Llc6118%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SenSura MioSenSura Mio BabySenSura Flex XproSensura FlexSenSura ClickSenSura Mio FlexSenSura FlexSenSura Mio ClickSenSura flexSenSura Click XproAssuraSenSura Mio KidsSafe N SimpleESTEEM+NATURASUR-FIT NATURA

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

FDA product codes

CodeNameDevices
EXBCOLLECTOR, OSTOMY178
EXEPROTECTOR, OSTOMY82
EZSAppliance, Colostomy, Disposable61
EXEProtector, Ostomy36
FONBag, drainage, with adhesive, ostomy4
EXBCollector, ostomy1

GMDN & GCC registration

  • GMDN code 48159 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 0% · OTC 65%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Lumen/Inner Diameter (Millimeter) · 252Length (Inch) · 35Height (Inch) · 34Total Volume (Milliliter) · 11Outer Diameter (Inch) · 10Lumen/Inner Diameter (Inch) · 7

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

How many intestinal ostomy base plate, flat products are registered in the US?

342 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intestinal ostomy base plate, flat", from 4 companies. The largest labeler is Convatec, Purchasing Department with 35% of records.

Which FDA product codes apply?

EXB (COLLECTOR, OSTOMY), EXE (PROTECTOR, OSTOMY), EZS (Appliance, Colostomy, Disposable), EXE (Protector, Ostomy)

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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