FDA UDI
In Commercial Distribution
🇺🇸 United States
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM
DI: 07540194011930
·
Model: BLT-GWR200-PKG6
·
Pega Medical Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM
- Primary DI
- 07540194011930
- Version / Model
- BLT-GWR200-PKG6
- Catalog Number
- BLT-GWR200-PKG6
- Company Name
- Pega Medical Inc
- Labeler DUNS
- 257315713
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2023-11-16
- Public Version
- 1
- Public Version Date
- 2023-11-24
- Public Version Status
- New
- Public Device Record Key
- 68a7bf2c-b343-4b27-9057-d04bbe7507a9
Device Description
BULLET GUIDEWIRE Ø2.0mm - PACKAGE OF 6
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
- Yes
- 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 |
|---|---|---|---|---|
| 46165 | Orthopaedic guidewire, reusable | A thin, non-implantable rod designed to guide the insertion of a cannulated orthopaedic implant (typically an intramedullary nail or screw) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). 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 | 07540194012746 | GS1 | ||||
| Primary | 07540194011930 | GS1 |
Customer Contacts
- Phone
- +1(450)688-5144 ext. 242
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2 | Millimeter |