FDA UDI
In Commercial Distribution
🇺🇸 United States
osmed Orbital Expander
DI: EOSMEXS1041
·
Model: 4.0ml
·
Osmed GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- osmed Orbital Expander
- Primary DI
- EOSMEXS1041
- Version / Model
- 4.0ml
- Catalog Number
- EXS-104
- Company Name
- Osmed GmbH
- Labeler DUNS
- 341784176
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-02
- Public Version
- 3
- Public Version Date
- 2019-09-23
- Public Version Status
- Update
- Public Device Record Key
- 0c6e4202-0f36-4078-9cee-53fc97b16821
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NFM | Expander, Tissue, Orbital | Ophthalmic | 886.3320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45187 | Skin-port tissue expander | An expandable device intended for implantation to temporarily enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of an implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube and an inflation valve, and is expanded percutaneously with air or fluid through a subcutaneous port accessed by a healthcare professional. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EOSMEXS1041 | HIBCC |