FDA UDI
Not in Commercial Distribution
🇺🇸 United States
BIOSORB - BIO1-S
DI: 03760154002196
·
Model: BIO1-S with Ø 0.6 mm granules
·
S.B.M
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BIOSORB - BIO1-S
- Primary DI
- 03760154002196
- Version / Model
- BIO1-S with Ø 0.6 mm granules
- Catalog Number
- B1S2692226
- Company Name
- S.B.M
- Labeler DUNS
- 772462123
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-16
- Public Version
- 4
- Public Version Date
- 2020-01-10
- Public Version Status
- Update
- Public Device Record Key
- 09a143ad-c8ae-4f96-b85d-1f7e9556d5e0
- Distribution End Date
- 2020-01-09
Device Description
Syringe pre-loaded with B-TCP granules (Absorbable calcium salt bone void filler)
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 |
|---|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | 888.3045 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16966 | Synthetic bone graft | An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03760154002196 | GS1 |
Customer Contacts
- Phone
- 781-369-1782
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071155 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 2 | Milliliter |