FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Hydroxyapatite Orbital Implant
DI: 05060171621867
·
Model: SP14
·
CERAMISYS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hydroxyapatite Orbital Implant
- Primary DI
- 05060171621867
- Version / Model
- SP14
- Company Name
- CERAMISYS LTD
- Labeler DUNS
- 423459374
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-07-31
- Public Version
- 4
- Public Version Date
- 2021-10-21
- Public Version Status
- Update
- Public Device Record Key
- bcd5e178-68b2-4afd-b0d3-a2332c6345be
- Distribution End Date
- 2021-10-20
Device Description
Porous Hydroxyapatite Orbital Implant, Sphere, 14mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| HPZ | Implant, Eye Sphere | Ophthalmic | 886.3320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46902 | Orbital sphere implant | An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060171621867 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110554 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius