| Primary Device ID | D7701447763 | 
| NIH Device Record Key | 79db61b3-e007-4f4d-8131-818c0dcb52ad | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | HANDLE | 
| Version Model Number | FLU-M | 
| Catalog Number | FLU-M | 
| 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 | D7701447763 [Primary] | 
| NDP | Accessories, Implant, Dental, Endosseous | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[D7701447763]
Moist Heat or Steam Sterilization
[D7701447763]
Moist Heat or Steam Sterilization
[D7701447763]
Moist Heat or Steam Sterilization
[D7701447763]
Moist Heat or Steam Sterilization
[D7701447763]
Moist Heat or Steam Sterilization
[D7701447763]
Moist Heat or Steam Sterilization
[D7701447763]
Moist Heat or Steam Sterilization
[D7701447763]
Moist Heat or Steam Sterilization
[D7701447763]
Moist Heat or Steam Sterilization
[D7701447763]
Moist Heat or Steam Sterilization
[D7701447763]
Moist Heat or Steam Sterilization
[D7701447763]
Moist Heat or Steam Sterilization
[D7701447763]
Moist Heat or Steam Sterilization
[D7701447763]
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 | 
| D7702707123 - STARTER PACK B4U | 2025-10-06 STARTER PACK B4U | 
| 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 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  HANDLE  97779930  not registered Live/Pending | RunBuggy OMI, Inc. 2023-02-03 | 
|  HANDLE  90052307  not registered Live/Pending | Healthcare Asset Network, Inc. 2020-07-14 | 
|  HANDLE  90032297  not registered Live/Pending | Garcia, Joseph 2020-07-02 | 
|  HANDLE  88690675  not registered Live/Pending | Handle, Inc. 2019-11-13 | 
|  HANDLE  88690649  not registered Live/Pending | Handle, Inc. 2019-11-13 | 
|  HANDLE  88690603  not registered Live/Pending | Handle, Inc. 2019-11-13 | 
|  HANDLE  88184749  not registered Live/Pending | Boston Dynamics, Inc. 2018-11-07 | 
|  HANDLE  87672873  not registered Dead/Abandoned | Kusters Zima Corporation 2017-11-06 | 
|  HANDLE  87393195  not registered Live/Pending | Handle Financial, Inc. 2017-03-30 | 
|  HANDLE  85726451  not registered Dead/Abandoned | Handle, Inc. 2012-09-11 | 
|  HANDLE  85381319  not registered Dead/Abandoned | Stranger & Stranger Inc 2011-07-26 | 
|  HANDLE  78594676  3066043 Live/Registered | HANDLE HOLDING LLC 2005-03-24 |