FDA UDI
In Commercial Distribution
🇺🇸 United States
CHS
DI: 03596010033130
·
Model: 110016
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CHS
- Primary DI
- 03596010033130
- Version / Model
- 110016
- Catalog Number
- 110016
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-29
- Public Version
- 4
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- edd15178-4a9c-4cec-949d-b0dfabedbb08
Device Description
CALIBRATED GUIDE PIN 3.2MM X 230MM
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
- 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 |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62058 | Cannulated surgical drill guiding pin | A sterile metal shaft (pin) designed to fit into the hollow centre of a cannulated surgical drill bit to provide a guide for drilling during a surgical procedure. The pin is bored into hard tissue (e.g., bone), typically by means of a surgical power tool handpiece, and the cannulated drill bit is subsequently fed over it during the drilling procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 23596010033134 | GS1 | BX | 6 | In Commercial Distribution | |
| Primary | 03596010033130 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]