| Primary Device ID | D7702694543 | 
| NIH Device Record Key | 838406ea-a0ff-4663-92ab-c3962a395e1f | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | SURGICAL KIT | 
| Version Model Number | ZGS-L-50-INT | 
| Catalog Number | ZGS-L-50-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 | |
| 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 | D7702694543 [Primary] | 
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[D7702694543]
Moist Heat or Steam Sterilization
[D7702694543]
Moist Heat or Steam Sterilization
[D7702694543]
Moist Heat or Steam Sterilization
[D7702694543]
Moist Heat or Steam Sterilization
[D7702694543]
Moist Heat or Steam Sterilization
[D7702694543]
Moist Heat or Steam Sterilization
[D7702694543]
Moist Heat or Steam Sterilization
[D7702694543]
Moist Heat or Steam Sterilization
[D7702694543]
Moist Heat or Steam Sterilization
[D7702694543]
Moist Heat or Steam Sterilization
[D7702694543]
Moist Heat or Steam Sterilization
[D7702694543]
Moist Heat or Steam Sterilization
[D7702694543]
Moist Heat or Steam Sterilization
[D7702694543]
Moist Heat or Steam Sterilization
[D7702694543]
Moist Heat or Steam Sterilization
[D7702694543]
Moist Heat or Steam Sterilization
[D7702694543]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-05-07 | 
| Device Publish Date | 2025-04-29 | 
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| D7702072673 | SURGICAL KIT FOR SHELTA IMPLANT SYSTEM | 
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| D7701515163 | SINUS LIFT FOR GUIDED SURGERY | 
| D7702693313 | SURGICAL KIT GS 5.0 | 
| D7702694543 | SURGICAL KIT PRAMA GS 5.0 | 
| D7702681423 | SURGICAL KIT FLUSILIFT EVO |