FDA UDI
In Commercial Distribution
🇺🇸 United States
KMEDIC
DI: 24026704292268
·
Model: IPN015736
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- KMEDIC
- Primary DI
- 24026704292268
- Version / Model
- IPN015736
- Catalog Number
- KM71006
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-16
- Public Version
- 10
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 96ec3c15-c640-40fd-8f43-fb57cc32e349
Device Description
DISP K-WIRE FOR .062" (1.6MM) 6.25"
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| HTY | PIN, FIXATION, SMOOTH | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12143 | Instrument tray, reusable | A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 04026704292264 | GS1 | ||||
| Primary | 24026704292268 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070561 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6.25 | Inch | |
| Device Size Text, specify | .063" (1.6MM) |