FDA UDI
In Commercial Distribution
🇺🇸 United States
IMPLANT EXTRACTOR
DI: D7702412983
·
Model: EXTR-IMP-S
·
SWEDEN & MARTINA SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IMPLANT EXTRACTOR
- Primary DI
- D7702412983
- Version / Model
- EXTR-IMP-S
- Catalog Number
- EXTR-IMP-S
- Company Name
- SWEDEN & MARTINA SPA
- Labeler DUNS
- 433815198
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-29
- Public Version
- 1
- Public Version Date
- 2025-11-06
- Public Version Status
- New
- Public Device Record Key
- 7dca82ec-be2a-4abf-babe-57fa1f695dbd
Device Description
IMPLANT EXTRACTOR SMALL
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62358 | Screw extractor, reusable | A hand-held manual surgical tool designed to remove implanted screws that have a damaged screw recess by self-tapping into the defective recess/head and providing sufficient grip to rotate and remove the screw in the normal way. It typically has a conical tip. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D7702412983 | HIBCC |
Customer Contacts
- Phone
- 844.862.7846
- [email protected]