FDA UDI
In Commercial Distribution
🇺🇸 United States
SilkVoice
DI: B611SV3001
·
Model: SV3001
·
SOFREGEN MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SilkVoice
- Primary DI
- B611SV3001
- Version / Model
- SV3001
- Catalog Number
- SV3001
- Company Name
- SOFREGEN MEDICAL INC.
- Labeler DUNS
- 079710838
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-21
- Public Version
- 1
- Public Version Date
- 2021-07-29
- Public Version Status
- New
- Public Device Record Key
- 5dbf43aa-5b0c-40a1-a6c8-2f22baf356de
Device Description
SilkVoice injectable implant and accessory kit.
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
- Yes
- 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 |
|---|---|---|---|---|
| MIX | System, Vocal Cord Medialization | Ear, Nose, Throat | 874.3620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42516 | Injectable vocal cord medialization implant, synthetic | An implantable synthetic material [e.g., calcium hydroxyapatite, polytetrafluoroethylene (PTFE) -- commonly known as Teflon] designed as a space-occupying bulking agent to treat patients with unilateral vocal cord paralysis to improve voice quality. The device is typically available in a sterile syringe with needle, and is injected into the paralyzed vocal cord tissue, filling it and shifting it midline (vocal cord medialization). The properties of the device may facilitate ingrowth of the surrounding tissue over time. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B611SV3001 | HIBCC |
Customer Contacts
- Phone
- 6176518873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180631 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 32 Degrees Celsius