FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SoundBite® Curving Tool 14
DI: 10754026505021
·
Model: 900-0001291
·
Soundbite Medical Solutions Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SoundBite® Curving Tool 14
- Primary DI
- 10754026505021
- Version / Model
- 900-0001291
- Company Name
- Soundbite Medical Solutions Inc
- Labeler DUNS
- 208993667
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-30
- Public Version
- 3
- Public Version Date
- 2021-06-30
- Public Version Status
- Update
- Public Device Record Key
- fcef0dea-7f67-4975-83cf-ee5b047473ca
- Distribution End Date
- 2021-06-30
Device Description
The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the active wire if desired. Its use is explained in the IFU.
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
- No
- 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 |
|---|---|---|---|---|
| PDU | Catheter For Crossing Total Occlusions | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63211 | Surgical probe/cannula bending tool | A sterile non-powered device designed to assist in the manual bending of a surgical handpiece tip, probe, or cannula to adjust the shape of the surgical device during surgery. It consists of a curved mould with a channel(s) to accept the surgical device and enable controlled manual bending. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10754026505021 | GS1 | ||||
| Package | 20754026505028 | GS1 | Box | 5 | Not in Commercial Distribution | 2021-06-30 |
Customer Contacts
- Phone
- 1-833-312-9181
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210839 | 000 |