SUPRAFOIL Code F-LSS-035
GUDID 10816848022923
SupraFOIL Nylon Foil Implant, 9x10cm, 0.35mm thickness
S JACKSON INC
Orbital rim prosthesis| Primary Device ID | 10816848022923 |
| NIH Device Record Key | c3d731a6-e01b-4ea2-b1d6-3110b5a60b7f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SUPRAFOIL |
| Version Model Number | Code F-LSS-035 |
| Catalog Number | Code F-LSS-035 |
| Company DUNS | 069277028 |
| Company Name | S JACKSON INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 8003685225 |
| sales@supramid.com | |
| Phone | 8003685225 |
| sales@supramid.com | |
| Phone | 8003685225 |
| sales@supramid.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816848022926 [Primary] |
| GS1 | 10816848022923 [Package] Contains: 00816848022926 Package: Box [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K973379
FDA Product Code
| FTM | Mesh, Surgical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-08-09 |
On-Brand Devices [SUPRAFOIL]
| 10816848023913 | SupraFOIL Nylon Foil Implant, 4x4cm, 0.8mm thickness |
| 10816848023746 | SupraFOIL Nylon Foil Implant, 4x4cm, 0.4mm thickness |
| 10816848022923 | SupraFOIL Nylon Foil Implant, 9x10cm, 0.35mm thickness |
| 10816848022909 | SupraFOIL Nylon Foil Implant, 4x4cm, 0.35mm thickness |
| 10816848024071 | SupraFOIL Nylon Foil Implant, 9x10cm, 0.35mm thickness |
Trademark Results [SUPRAFOIL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUPRAFOIL 77021833 3278674 Live/Registered |
S. Jackson, Inc. 2006-10-16 |
 SUPRAFOIL 74448363 1896904 Dead/Cancelled |
S. JACKSON, INC. 1993-10-18 |
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