FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOVIVA-3D DENTAL
DI: 00817169021056
·
Model: SBB684
·
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BIOVIVA-3D DENTAL
- Primary DI
- 00817169021056
- Version / Model
- SBB684
- Company Name
- 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
- Labeler DUNS
- 080194935
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-12
- Public Version
- 6
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 8d99eac4-f6fc-45fb-902e-447ffaa39daa
Device Description
SILK SUTURE 3-0 REVERSE CUTTING 24MM 3/8 45CM One Device
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 |
|---|---|---|---|---|
| GAP | Suture, Nonabsorbable, Silk | General, Plastic Surgery | 878.5030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13910 | Silk suture | A natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of 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 | 00817169021056 | GS1 | ||||
| Package | 00817169020929 | GS1 | 12 | In Commercial Distribution | ||
| Package | 10817169021053 | GS1 | 12 | In Commercial Distribution |