| Primary Device ID | D7702693383 |
| NIH Device Record Key | 44e87bb4-be29-4757-93ab-452bca67b759 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MOUNTER |
| Version Model Number | GS-MOU-AS380-50 |
| Catalog Number | GS-MOU-AS380-50 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D7702693383 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D7702693383]
Moist Heat or Steam Sterilization
[D7702693383]
Moist Heat or Steam Sterilization
[D7702693383]
Moist Heat or Steam Sterilization
[D7702693383]
Moist Heat or Steam Sterilization
[D7702693383]
Moist Heat or Steam Sterilization
[D7702693383]
Moist Heat or Steam Sterilization
[D7702693383]
Moist Heat or Steam Sterilization
[D7702693383]
Moist Heat or Steam Sterilization
[D7702693383]
Moist Heat or Steam Sterilization
[D7702693383]
Moist Heat or Steam Sterilization
[D7702693383]
Moist Heat or Steam Sterilization
[D7702693383]
Moist Heat or Steam Sterilization
[D7702693383]
Moist Heat or Steam Sterilization
[D7702693383]
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 |
| D7702693383 | MOUNTER SLEEVE 5.0 COLLEX 3.30 |
| D7702693373 | MOUNTER SLEEVE 5.0 COLLEX 3.30 (6PCS) |
| D7702693353 | MOUNTER SLEEVE 5.0 EX 2.30 MM |
| D7702693343 | MOUNTER SLEEVE 5.0 EX 2.30 MM (6PCS) |
| D7702690793 | MOUNTER SLEEVE 5.0 COLLEX 3.30 |