FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Molteno
DI: 09419196000083
·
Model: P1
·
MOLTENO OPHTHALMIC LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Molteno
- Primary DI
- 09419196000083
- Version / Model
- P1
- Catalog Number
- P1
- 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
- 5
- Public Version Date
- 2025-07-02
- Public Version Status
- Update
- Public Device Record Key
- 9bf2f22c-d202-4d58-803f-a493a1bb4e25
- Distribution End Date
- 2023-06-15
Device Description
P1 Paediatric/Microphthalmic 8mm Molteno Implant - Sterile
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 |
|---|---|---|---|---|
| KYF | Implant, Eye Valve | Ophthalmic | 886.3920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61127 | Glaucoma shunt | A non-bioabsorbable, implantable ocular device intended to create an artificial drainage channel for diversion of aqueous humour from the anterior chamber of the eye to reduce intraocular pressure (IOP) as an alternative to, or after failed, trabeculectomy, for the management of uncontrolled glaucoma. It consists of a tube which is introduced into the aqueous body (typically via limbal entry) and a distal episcleral plate intended to support a reservoir of aqueous humour; the shunt does not contain a valve. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09419196000083 | GS1 |
Customer Contacts
- Phone
- +6434792744
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 8 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 75 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius