FDA UDI
In Commercial Distribution
🇺🇸 United States
K-Wire and Steinmann Pin Dispensers
DI: 10849771043154
·
Model: KI-049-05PT1.5
·
KEY SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- K-Wire and Steinmann Pin Dispensers
- Primary DI
- 10849771043154
- Version / Model
- KI-049-05PT1.5
- Catalog Number
- KI04905PT15
- Company Name
- KEY SURGICAL, INC.
- Labeler DUNS
- 604056226
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2022-11-22
- Public Version
- 1
- Public Version Date
- 2022-11-30
- Public Version Status
- New
- Public Device Record Key
- 39de231e-2ef9-487f-a07f-9d24eeff1845
Device Description
K-Wires, Single Trocar, 1.5cm partially threaded, 0.049-inch (1.25mm) diameter, 5.90-inch (150mm) length
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
- 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
- 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 |
|---|---|---|---|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61918 | Orthopaedic bone pin container | A non-sterile cylindrical device intended to temporarily hold one or more orthopaedic pin(s) [e.g., K-wires] during sterilization and a surgical procedure for protection against damage. It is made of metal (e.g., stainless steel) and is typically a cylinder with a screw top, with lateral fenestrations to enable the penetration of sterilization fluid. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00849771043157 | GS1 | ||||
| Primary | 10849771043154 | GS1 |
Customer Contacts
- Phone
- +1(800)541-7995
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.049 | Inch | |
| Length | 5.9 | Inch |