FDA UDI
In Commercial Distribution
🇺🇸 United States
PONTiS Flexor Tendon Repair System
DI: 00859210006025
·
Model: 400-3031
·
PONTIS ORTHOPAEDICS, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PONTiS Flexor Tendon Repair System
- Primary DI
- 00859210006025
- Version / Model
- 400-3031
- Catalog Number
- 400-3031
- Company Name
- PONTIS ORTHOPAEDICS, LLC
- Labeler DUNS
- 047775061
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 5
- Public Version Date
- 2019-03-21
- Public Version Status
- Update
- Public Device Record Key
- 8e342132-b741-4037-aad3-af0e366c7ece
Device Description
PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains: 1x 3mm Anchor with Driver handle Anchor has size #3-0 multifilament SS suture Each end of SS suture has pre-attached straight needles. Supplied pouched, sterilized with EO.
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | General, Plastic Surgery | 878.4495 | 2 |
| 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 | 00859210006025 | GS1 |
Customer Contacts
- Phone
- 415-567-8935
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4.5 | Millimeter | |
| Outer Diameter | 3 | Millimeter |