| Primary Device ID | D7701241263 |
| NIH Device Record Key | fdcc88eb-9ba1-4d4d-8e54-68f543a1cf95 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SURG. KIT FOR PREMIUM-SHELTA |
| Version Model Number | ZPRESH-INT |
| Catalog Number | ZPRESH-INT |
| Company DUNS | 433815198 |
| Company Name | SWEDEN & MARTINA SPA |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | 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 | |
| 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 | D7701241263 [Primary] |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D7701241263]
Moist Heat or Steam Sterilization
[D7701241263]
Moist Heat or Steam Sterilization
[D7701241263]
Moist Heat or Steam Sterilization
[D7701241263]
Moist Heat or Steam Sterilization
[D7701241263]
Moist Heat or Steam Sterilization
[D7701241263]
Moist Heat or Steam Sterilization
[D7701241263]
Moist Heat or Steam Sterilization
[D7701241263]
Moist Heat or Steam Sterilization
[D7701241263]
Moist Heat or Steam Sterilization
[D7701241263]
Moist Heat or Steam Sterilization
[D7701241263]
Moist Heat or Steam Sterilization
[D7701241263]
Moist Heat or Steam Sterilization
[D7701241263]
Moist Heat or Steam Sterilization
[D7701241263]
Moist Heat or Steam Sterilization
[D7701241263]
Moist Heat or Steam Sterilization
[D7701241263]
Moist Heat or Steam Sterilization
[D7701241263]
Moist Heat or Steam Sterilization
[D7701241263]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-23 |
| D7701556003 - PRAMA RF IMPLANT ZIRTI | 2025-08-12 PRAMA RF IMPLANT ZIRTI WIDE THREAD D. 3.80 H. 18 MM |
| D7701556073 - PRAMA RF IMPLANT ZIRTI | 2025-08-12 PRAMA RF IMPLANT ZIRTI WIDE THREAD D. 4.25 H. 18 MM |
| D7701609403 - STOP FOR CONICAL DRILL | 2025-08-01 STOP FOR CONICAL DRILL D.2.00-D.2.50 - H.18MM |
| D7701609413 - STOP FOR CONICAL DRILL | 2025-08-01 STOP FOR CONICAL DRILL D.2.00-D.2.50 - H.19MM |
| D7701609433 - STOP FOR CONICAL DRILL | 2025-08-01 STOP FOR CONICAL DRILL D.2.00-D.2.50 - H.21MM |
| D7701609443 - STOP FOR CONICAL DRILL | 2025-08-01 STOP FOR CONICAL DRILL D.2.00-D.2.50 - H.22MM |
| D7701609463 - STOP FOR CONICAL DRILL | 2025-08-01 STOP FOR CONICAL DRILL D.2.00-D.2.50 - H.24MM |
| D7701609483 - STOP FOR CONICAL DRILL | 2025-08-01 STOP FOR CONICAL DRILL D.2.00-D.2.50 - H.26MM |