Identity
- Trade Name
- osmed Orbital Expander FDA UDI
- Generic Name
- Skin-port tissue expander FDA UDI
- Device Name
- osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacrylate-n-vinylpyrrolidone-co-polymer) using the osmotic principle to expand physiological tissue space due to the absorption of body fluid from the surrounding tissues. The osmed Orbital Expanders are used for expansion of the orbita at congenital anophthalmia and microphthalmia. FDA UDI
- Model / Reference
- 5.0ml FDA UDI
- Description
- osmed self-inflating tissue expanders are made of a specially developed hydrogel (methylmethacrylate-n-vinylpyrrolidone-co-polymer) using the osmotic principle to expand physiological tissue space due to the absorption of body fluid from the surrounding tissues. The osmed Orbital Expanders are used for expansion of the orbita at congenital anophthalmia and microphthalmia. FDA UDI
Identifiers
- Catalog Number
- EXS-105 FDA UDI
- Primary DI / UDI-DI
- EOSMEXS1051 FDA UDI
- FDA Product Code
- NFM FDA UDI
- GMDN Term
- Skin-port tissue expander FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.3320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin-port tissue expander
osmed Orbital Expander by Osmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Osmed, Inc.
Sources (1)
- FDA UDI 2a0f3ec8-18a3-406d-abc3-8c74561617f3 34 fields · synced May 30, 2026