FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Molteno M-Sphere
DI: 09419196000182
·
Model: MS20
·
MOLTENO OPHTHALMIC LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Molteno M-Sphere
- Primary DI
- 09419196000182
- Version / Model
- MS20
- Catalog Number
- MS20
- Company Name
- MOLTENO OPHTHALMIC LIMITED
- Labeler DUNS
- 760385075
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-12
- Public Version
- 3
- Public Version Date
- 2023-06-15
- Public Version Status
- Update
- Public Device Record Key
- de3e4da6-e454-4c83-9c1b-c854ca2e3c1b
- Distribution End Date
- 2023-06-15
Device Description
MS20 - Molteno M-Sphere® 20mm Natural Hydroxyapatite Orbital Implant
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 48097 | Bone matrix implant, animal-derived, non-bioabsorbable | A sterile non-bioabsorbable device made primarily of animal-derived bone matrix (e.g., heat-treated hydroxyapatite ceramic from animal cancellous bone) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill bone cavities, defects, and fractures, and contains pores that promote the ingrowths of endogenous bone for skeletal reconstruction or augmentation. It is typically provided as cancellous blocks, cylinders, or granules. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09419196000182 | GS1 |
Customer Contacts
- Phone
- +6434792744
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 20 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 75 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius