Identity
- Trade Name
- osmed Hemisphere 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 Hemisphere Expanders are used for expansion of the connecting tissue sack at congenital anophthalmia and microphthalmia. FDA UDI
- Model / Reference
- 1.5ml 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 Hemisphere Expanders are used for expansion of the connecting tissue sack at congenital anophthalmia and microphthalmia. FDA UDI
Identifiers
- Catalog Number
- 352-6150 FDA UDI
- Primary DI / UDI-DI
- EOSM35261501 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 Hemisphere 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 5c820fad-97b9-43c6-bd30-72721a8c982f 34 fields · synced May 30, 2026