| Primary Device ID | D7702681423 |
| NIH Device Record Key | bade5dff-c176-4d09-9956-14009bab76a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SURGICAL KIT |
| Version Model Number | ZFLU-EVO-INT |
| Catalog Number | ZFLU-EVO-INT |
| Company DUNS | 433815198 |
| Company Name | SWEDEN & MARTINA SPA |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Manufacturing Date | false |
| 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 | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com | |
| Phone | 844.862.7846 |
| info.us@sweden-martina.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D7702681423 [Primary] |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D7702681423]
Moist Heat or Steam Sterilization
[D7702681423]
Moist Heat or Steam Sterilization
[D7702681423]
Moist Heat or Steam Sterilization
[D7702681423]
Moist Heat or Steam Sterilization
[D7702681423]
Moist Heat or Steam Sterilization
[D7702681423]
Moist Heat or Steam Sterilization
[D7702681423]
Moist Heat or Steam Sterilization
[D7702681423]
Moist Heat or Steam Sterilization
[D7702681423]
Moist Heat or Steam Sterilization
[D7702681423]
Moist Heat or Steam Sterilization
[D7702681423]
Moist Heat or Steam Sterilization
[D7702681423]
Moist Heat or Steam Sterilization
[D7702681423]
Moist Heat or Steam Sterilization
[D7702681423]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-01 |
| Device Publish Date | 2025-06-23 |
| D7701323493 | SURGICAL KIT FOR ESTAG TECHNIQUE |
| D7701304973 | SURGICAL KIT FOR PREMIUM ONE IMPLANT SYSTEM |
| D7701300713 | SURGICAL KIT FOR SHELTA IMPLANT SYSTEM |
| D7701103063 | SURGICAL KIT FOR SHELTA IMPLANT SYSTEM |
| D7701045423 | SURGICAL KIT FOR GLOBAL IMPLANT SYSTEM |
| D7700896403 | SURGICAL KIT FOR OUTLINK2 IMPLANT SYSTEM |
| D7700896393 | SURGICAL KIT FOR PRE/KOH IMPLANT SYSTEM |
| D7700896373 | SURGICAL KIT FOR PREMIUM IMPLANT SYSTEM |
| D7701481643 | SURGICAL KIT (LARGE) FOR PRAMA IMPLANTS |
| D7701353953 | SURGICAL KIT 2DRILL FOR GUIDED SURGERY |
| D7702072673 | SURGICAL KIT FOR SHELTA IMPLANT SYSTEM |
| D7701330763 | SURGICAL KIT FOR PRE/KOH ONE IMPLANT SYSTEM |
| D7701515163 | SINUS LIFT FOR GUIDED SURGERY |
| D7702693313 | SURGICAL KIT GS 5.0 |
| D7702694543 | SURGICAL KIT PRAMA GS 5.0 |
| D7702681423 | SURGICAL KIT FLUSILIFT EVO |