FDA UDI
In Commercial Distribution
🇺🇸 United States
LIGAFIX
DI: 03760154003995
·
Model: LIGAFIX complete Blind Tunnel instrumentation set
·
S.B.M
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LIGAFIX
- Primary DI
- 03760154003995
- Version / Model
- LIGAFIX complete Blind Tunnel instrumentation set
- Catalog Number
- LIG90TB000
- Company Name
- S.B.M
- Labeler DUNS
- 772462123
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-12
- Public Version
- 2
- Public Version Date
- 2024-06-21
- Public Version Status
- Update
- Public Device Record Key
- 80bec9b6-0e92-48f5-8f84-3758e30090df
Device Description
Surgical Instrument Set consisting of reusable surgical instruments intended to be used during arthroscopic implantation of the LIGAFIX interference screw for ACL reconstruction (Blind tunnel technique).
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 44091 | Arthroscopic surgical procedure kit, non-medicated, reusable | A collection of various surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03760154003995 | GS1 |