FDA UDI
In Commercial Distribution
🇺🇸 United States
RIGIDLOOP
DI: 10886705022830
·
Model: 232037
·
Medos International Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RIGIDLOOP
- Primary DI
- 10886705022830
- Version / Model
- 232037
- Catalog Number
- 232037
- Company Name
- Medos International Sàrl
- Labeler DUNS
- 482661753
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-01
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 281dd793-1983-450b-841b-b7bb0c6cbc4f
Device Description
RIGIDLOOP Disposables Kit 4.5mm Cannulated Reamer (20-130mm Plus or Minus 0.1mm), RIGIDLOOP Beath Pin, Single use Depth Gauge (10-130mm Plus or Minus 0.3mm), 1.1mm x 15 Inches (38 cm) Nitinol Guidewire, Threaded Tibial Cannula, Malleable Graft Retractor, Marking Pen, Ruler (0-15cm Plus or Minus 0.5mm)
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDD | KIT, SURGICAL INSTRUMENT, DISPOSABLE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44052 | Orthopaedic surgical procedure kit, non-medicated, single-use | A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10886705022830 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]