FDA UDI
In Commercial Distribution
🇺🇸 United States
Biosteon® IntraLine®
DI: 15060155711192
·
Model: 3910-200-084
·
BIOCOMPOSITES LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Biosteon® IntraLine®
- Primary DI
- 15060155711192
- Version / Model
- 3910-200-084
- Catalog Number
- 3910-200-084
- Company Name
- BIOCOMPOSITES LTD
- Labeler DUNS
- 424382307
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-06-30
- Public Version
- 4
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- c4f1892a-dd94-47f7-a5a2-debbf9c52b45
Device Description
The Biosteon® IntraLine® 6.5mm HA/PLLA Suture Anchor with two #2 Force Fibre®, is a single use device. It is made from a resorbable composite which will gradually be resorbed into the body. This function however is patient dependent. The device is supplied sterile. The device is intended to secure a suture or sutures to bone that are then used to reattach damaged soft tissue in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis. The device is supplied with polyethylene sutures.
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 |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45039 | Bioabsorbable orthopaedic bone screw | A small, threaded, implantable rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). There are several kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15060155711192 | GS1 | ||||
| Package | 35060155711196 | GS1 | Sleeve | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +441782338580
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 6.5 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 117 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 47 Degrees Celsius