A sterile flexible cylinder intended to assist with the delivery of a prefilled breast implant by providing a low-friction shell-tissue interface during implant insertion into a surgically-created breast pocket, without constricting the size of the implant. It
| Company | Devices | Share |
|---|---|---|
| Sigvaris Inc | 67 | 97% |
| Allergan, Inc. | 2 | 3% |
Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| KMO | Binder, Elastic | 67 |
| KDD | Kit, Surgical Instrument, Disposable | 2 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
69 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Breast implant delivery sleeve", from 2 companies. The largest labeler is Sigvaris Inc with 97% of records.
KMO (Binder, Elastic), KDD (Kit, Surgical Instrument, Disposable)
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.