FDA UDI
In Commercial Distribution
🇺🇸 United States
PONTiS Flexor Tendon Repar System
DI: 00859210006049
·
Model: 400-3015
·
PONTIS ORTHOPAEDICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PONTiS Flexor Tendon Repar System
- Primary DI
- 00859210006049
- Version / Model
- 400-3015
- Catalog Number
- 400-3015
- 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
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 337590e8-ff06-454b-a312-0f3290baaad9
Device Description
PONTiS Pre-drill Refill Pack for Flexor Tendon Repair Each Kit contains: 1x Pre-drill, size 0.063" diameter x 4" length 1x Pre-drill, size 0.078" diameter x 4" length 1x Pre-drill, size 0.094" diameter x 4" length > For replacement of components of the PONTiS Crimp Instrument Sets (p/n 400-5563 or 400-5565) Supplied Non-Sterile.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Dry Heat Sterilization", "Moist Heat or Steam 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 |
|---|---|---|---|---|
| 47457 | Orthopaedic trocar blade, reusable | A rigid hand-held surgical instrument with a sharp (pyramidal or conical) point designed to be used during orthopaedic surgery for the manual puncture of a bodily entry point to: 1) gently part the surrounding soft tissue upon entry; 2) assist in the location and positioning of skeletal fractures; and/or 3) assist alignment of surgical instruments/implants. It is typically made of high-grade stainless steel, titanium (Ti), or synthetic material. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859210006049 | GS1 |
Customer Contacts
- Phone
- 415-567-8935
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4 | Inch | |
| Outer Diameter | 0.094 | Inch | |
| Outer Diameter | 0.078 | Inch | |
| Outer Diameter | 0.063 | Inch |