FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSIOfiber® Suture Anchor
DI: 07290017630625
·
Model: OF1034753S
·
OSSIO LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OSSIOfiber® Suture Anchor
- Primary DI
- 07290017630625
- Version / Model
- OF1034753S
- Catalog Number
- OF1034753S
- Company Name
- OSSIO LTD
- Labeler DUNS
- 600505107
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-06
- Public Version
- 1
- Public Version Date
- 2022-06-14
- Public Version Status
- New
- Public Device Record Key
- 957e1692-1928-4011-9038-e6fb190f59b2
Device Description
OSSIOfiber® Suture Anchor 4.75 mm with Needles, Black/White Tape, Blue #2 Suture. Package contains: 1 Implant, 1 Inserter, 1 Black/White 1.8mm Suture Tape, 1 Blue Round #2 Suture, 4 Stainless Steel MO-6 Needles.
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 |
|---|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45061 | Tendon/ligament bone anchor, bioabsorbable | A bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290017630625 | GS1 |
Customer Contacts
- Phone
- 1-833-781-7373
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213415 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 4.75 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not expose product to temperatures greater than 47°C or 116°F
- Type
- Storage Environment Temperature
- Temperature Range
- 7 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at a normal relative humidity