| Primary Device ID | 07649990202297 |
| NIH Device Record Key | 4d86ee96-fbf3-40b5-b679-9f762fa8c233 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Guide S-PI / W5.0 |
| Version Model Number | Guide S-PI / W5.0 |
| Catalog Number | G04-001 |
| Company DUNS | 482948937 |
| Company Name | Surgical Fusion Technologies GmbH |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +41442046018 |
| complaints@surgical-fusion.com | |
| Phone | +41442046018 |
| complaints@surgical-fusion.com | |
| Phone | +41442046018 |
| complaints@surgical-fusion.com | |
| Phone | +41442046018 |
| complaints@surgical-fusion.com | |
| Phone | +41442046018 |
| complaints@surgical-fusion.com | |
| Phone | +41442046018 |
| complaints@surgical-fusion.com | |
| Phone | +41442046018 |
| complaints@surgical-fusion.com | |
| Phone | +41442046018 |
| complaints@surgical-fusion.com | |
| Phone | +41442046018 |
| complaints@surgical-fusion.com | |
| Phone | +41442046018 |
| complaints@surgical-fusion.com | |
| Phone | +41442046018 |
| complaints@surgical-fusion.com | |
| Phone | +41442046018 |
| complaints@surgical-fusion.com | |
| Phone | +41442046018 |
| complaints@surgical-fusion.com | |
| Phone | +41442046018 |
| complaints@surgical-fusion.com | |
| Phone | +41442046018 |
| complaints@surgical-fusion.com | |
| Phone | +41442046018 |
| complaints@surgical-fusion.com | |
| Phone | +41442046018 |
| complaints@surgical-fusion.com | |
| Phone | +41442046018 |
| complaints@surgical-fusion.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07649990202297 [Primary] |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07649990202297]
Moist Heat or Steam Sterilization
[07649990202297]
Moist Heat or Steam Sterilization
[07649990202297]
Moist Heat or Steam Sterilization
[07649990202297]
Moist Heat or Steam Sterilization
[07649990202297]
Moist Heat or Steam Sterilization
[07649990202297]
Moist Heat or Steam Sterilization
[07649990202297]
Moist Heat or Steam Sterilization
[07649990202297]
Moist Heat or Steam Sterilization
[07649990202297]
Moist Heat or Steam Sterilization
[07649990202297]
Moist Heat or Steam Sterilization
[07649990202297]
Moist Heat or Steam Sterilization
[07649990202297]
Moist Heat or Steam Sterilization
[07649990202297]
Moist Heat or Steam Sterilization
[07649990202297]
Moist Heat or Steam Sterilization
[07649990202297]
Moist Heat or Steam Sterilization
[07649990202297]
Moist Heat or Steam Sterilization
[07649990202297]
Moist Heat or Steam Sterilization
[07649990202297]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-22 |
| Device Publish Date | 2024-04-12 |
| 07649990202419 - Drill S-PI-A1.6 extra short | 2026-01-26 Drill extra short for SF Push-in Anchor 1.6 |
| 07649990202020 - Tray_SF Push-In Anchor 2.3 | 2024-11-29 Tray SF Push-in Anchor 2.3 |
| 07649990202075 - SupraFuser Generator | 2024-04-22 |
| 07649990202228 - SF Push-in Anchor 1.6 | 2024-04-22 |
| 07649990202235 - SF Push-in Anchor 3.0 | 2024-04-22 |
| 07649990202259 - Stopper S-PI-A1.6 | 2024-04-22 Stopper for Ultrasonic Handpiece for SF Push-in Anchor 1.6 |
| 07649990202266 - Stopper S-PI-A2.3 | 2024-04-22 Stopper for Ultrasonic Handpiece for SF Push-in Anchor 2.3 |
| 07649990202273 - Stopper S-PI-A3.0 | 2024-04-22 Stopper for Ultrasonic Handpiece for SF Push-in Anchor 3.0 |