FDA UDI
Not in Commercial Distribution
🇺🇸 United States
K-Wire and Steinmann Pin Dispensers
DI: 00849771008323
·
Model: KE-1220
·
KEY SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- K-Wire and Steinmann Pin Dispensers
- Primary DI
- 00849771008323
- Version / Model
- KE-1220
- Catalog Number
- KE1220
- Company Name
- KEY SURGICAL, INC.
- Labeler DUNS
- 604056226
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-21
- Public Version
- 4
- Public Version Date
- 2023-09-26
- Public Version Status
- Update
- Public Device Record Key
- a880dbbe-1762-4098-b6e8-a21dca69be5f
- Distribution End Date
- 2023-09-25
Device Description
Raw, K-Wire and Steinmann Pin Dispensers, Multi-Chambered, 12-inch, Holds .035, .045, .054, .062 k-wires
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00849771008323 | GS1 |
Customer Contacts
- Phone
- +1(800)541-7995
- [email protected]