RAPHAEL 25 Instrument Kit
Basic Information
- Brand Name
- RAPHAEL 25 Instrument Kit
- Primary DI
- 07290019507079
- Version / Model
- 100-606
- Company Name
- OTS MEDICAL LTD
- Labeler DUNS
- 600883165
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-30
- Public Version
- 1
- Public Version Date
- 2026-04-07
- Public Version Status
- New
- Public Device Record Key
- ed17025a-6047-4c57-a831-f5f3fcccdf31
Device Description
Raphael 25 is an all-suture anchor. It is a soft-tissue fixation device with an expandable push-in design, provided preloaded on a disposable inserter. The device is constructed of a flat suture sleeve that is interlaced longitudinally along its central width by two #2 suture strands. The flat suture sleeve and the double loaded suture strands are folded back on themselves at the distal end of the disposable inserter. The device consists of the following components and accessories: non-absorbable, single use, suture anchor is made of a braided polyester sleeve; inserter; drill bit; and drill guide are made of stainless steel; and drill guide obturator is made of polypropylene. The disposable inserter has a stainless-steel shaft supporting a forked shaped tip, with a handle, and is provided sterile, for single use.
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
- MR Safe
- 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
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45062 | Tendon/ligament bone anchor, non-bioabsorbable | A non-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 cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)]. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290019507079 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251310 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 8 – Degrees Celsius