FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSIOfiber® Suture Anchor System
DI: 07290017630663
·
Model: OF2034756S
·
OSSIO LTD
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OSSIOfiber® Suture Anchor System
- Primary DI
- 07290017630663
- Version / Model
- OF2034756S
- Catalog Number
- OF2034756S
- 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
- c2e5ce17-ab33-49b8-bfb5-1c302332c8b4
Device Description
OSSIOfiber® Suture Anchor System - Two 4.75 mm with Tape, #2 Sutures, with Needles. Package contains: 1 OSSIOfiber Suture Anchor, 4.75 mm, Black Tape & Blue/White #2 Sutures with Needles; 1 OSSIOfiber Suture Anchor, 4.75 mm, Black/White Tape & Blue #2 Sutures with Needles; 1 OSSIO Drill Bit & Drill Guide.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| OJH | Orthopedic Tray | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44052 | Orthopaedic surgical procedure kit, non-medicated, single-use | A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device. | No | Active |
| 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 | 07290017630663 | GS1 |
Customer Contacts
- Phone
- 1-833-781-7373
- [email protected]
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