FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Argus II Retinal Prosthesis Retinal Tacks
DI: 10856264005322
·
Model: 011006-001
·
Second Sight Medical Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Argus II Retinal Prosthesis Retinal Tacks
- Primary DI
- 10856264005322
- Version / Model
- 011006-001
- Catalog Number
- 011006
- Company Name
- Second Sight Medical Products, Inc.
- Labeler DUNS
- 086470742
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2014-12-16
- Public Version
- 4
- Public Version Date
- 2023-05-18
- Public Version Status
- Update
- Public Device Record Key
- 2ee264eb-f10f-48ea-be96-2b88f310a1c5
- Distribution End Date
- 2023-03-31
Device Description
The Argus II Retinal Tack is used to affix the electrode array of the Retinal Prosthesis to the retina.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| NBF | Prosthesis,Retinal | Unknown | f |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57798 | Retinal tack | A sterile, non-bioabsorbable, implantable device designed to permanently fix a detached retina to the underlying retinal pigment epithelium (RPE) during ophthalmic surgery. It typically includes a conical, sharply-pointed forward end portion, an elongated cylindrical retaining portion, including one or more peripheral grooves for receiving displaced sclera tissue, and an enlarged head with a flange portion for engaging the retina in the area of the opening formed in the retina; it is intended to be pierced through the retina, choroid membrane, and sclera. The device is typically made of titanium (Ti), surgical-grade stainless steel, or a synthetic material. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10856264005322 | GS1 | ||||
| Unit of Use | 00856264005325 | GS1 |
Customer Contacts
- Phone
- (818) 833-5027
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H110002 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 131 Degrees Fahrenheit