FDA UDI
In Commercial Distribution
🇺🇸 United States
SUPRAFOIL
DI: 00816848023916
·
Model: Code F-SS-08
·
S JACKSON INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SUPRAFOIL
- Primary DI
- 00816848023916
- Version / Model
- Code F-SS-08
- Catalog Number
- Code F-SS-08
- Company Name
- S JACKSON INC
- Labeler DUNS
- 069277028
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-19
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- d6c8c2b1-b0ed-4107-8749-3821534e1636
Device Description
SupraFOIL Nylon Foil Implant, 4x4cm, 0.8mm thickness
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 |
|---|---|---|---|---|
| FTM | Mesh, Surgical | General, Plastic Surgery | 878.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35677 | Orbital rim prosthesis | A sterile implantable ocular device used to reconstruct the floor of the bony cavity that contains the eyeball and its associated muscles, vessels, and nerves, (i.e., the orbital floor and/or rim of the eye socket), and is intended to house an artificial eye. It may be constructed of one of a variety of materials, or a combination, including stainless steel, titanium (Ti), titanium alloy, or flexible mesh alloplastics. It is an aspherical orbital volume replacement prosthesis that will typically have a spongy outer surface (e.g., reinforced with surgical mesh) designed to encourage tissue attachment. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816848023913 | GS1 | Box | 6 | In Commercial Distribution | |
| Primary | 00816848023916 | GS1 |
Customer Contacts
- Phone
- 8003685225
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K973379 | 000 |