FDA UDI
In Commercial Distribution
🇺🇸 United States
Bonopty Adapter
DI: 07350031352504
·
Model: 250
·
Apriomed AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Bonopty Adapter
- Primary DI
- 07350031352504
- Version / Model
- 250
- Catalog Number
- 250
- Company Name
- Apriomed AB
- Labeler DUNS
- 631734758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-04
- Public Version
- 3
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- 63e2909d-7dc8-4af9-b235-e2499d913f44
- Distribution End Date
- 2026-02-26
Device Description
Universal connector compatible with AprioMed Bonopty drills.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HXY | Brace, Drill | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65126 | Surgical instrument handle grip | A device designed specifically to be attached to the handle (or holding portion) of a surgical instrument to provide grip for improved manipulation of the handle during surgical procedures. It is typically a synthetic polymer device designed for attachment to a handle and is not intended to provide a physical sterile barrier between the handle and the hand of a healthcare professional (i.e., not a handle cover). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17350031352501 | GS1 | Shelf box | 5 | Not in Commercial Distribution | 2026-02-26 |
| Primary | 07350031352504 | GS1 | ||||
| Package | 27350031352508 | GS1 | Transportation box | 12 | In Commercial Distribution | 2026-02-26 |
Customer Contacts
- Phone
- +46184301440
- [email protected]