FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Key Surgical K-Wire and Pin Covers
DI: 00849771008231
·
Model: C-062NS
·
KEY SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Key Surgical K-Wire and Pin Covers
- Primary DI
- 00849771008231
- Version / Model
- C-062NS
- Catalog Number
- C-062NS
- Company Name
- KEY SURGICAL, INC.
- Labeler DUNS
- 604056226
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2020-12-09
- Public Version
- 5
- Public Version Date
- 2023-04-18
- Public Version Status
- Update
- Public Device Record Key
- 40986401-53ad-4f2d-b32f-bb8a2ee149e3
- Distribution End Date
- 2023-04-17
Device Description
K-Wire Covers, Non-Sterile, Green, .062-inch, 1.6mm, Bulk
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63247 | Surgical instrument guard, single-use | A device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00849771043652 | GS1 | ||||
| Primary | 00849771008231 | GS1 |
Customer Contacts
- Phone
- +1(800)541-7995
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | .062 | Inch |