FDA UDI
In Commercial Distribution
🇺🇸 United States
KMEDIC
DI: 24026704282276
·
Model: IPN014843
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- KMEDIC
- Primary DI
- 24026704282276
- Version / Model
- IPN014843
- Catalog Number
- KM49660
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-15
- Public Version
- 2
- Public Version Date
- 2021-01-18
- Public Version Status
- Update
- Public Device Record Key
- 07a84201-5b3b-42fe-aebf-2c0d73650e0b
Device Description
CHISEL BLADE 16 MILLIMETER STRAIGHT FOR KM49-630
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GFI | OSTEOTOME, MANUAL | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34938 | Orthopaedic chisel blade | A device that is an interchangeable component of an orthopaedic chisel and functions as the cutting blade which is attached and locked to a dedicated handle. Together, they become a single-blade surgical instrument, bevelled on one side, intended to cut or contour bone. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design and is typically made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 24026704282276 | GS1 | ||||
| Direct Marking | 04026704282272 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Straight | ||
| Length | 81.3 | Millimeter | |
| Width | 16 | Millimeter |