FDA UDI
In Commercial Distribution
🇺🇸 United States
4CIS® Riviera Disposable Retractor System
DI: 08800033350569
·
Model: 4901-0076
·
SOLCO BIOMEDICAL CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 4CIS® Riviera Disposable Retractor System
- Primary DI
- 08800033350569
- Version / Model
- 4901-0076
- Catalog Number
- 4901-0076
- Company Name
- SOLCO BIOMEDICAL CO.,LTD.
- Labeler DUNS
- 687844241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-26
- Public Version
- 1
- Public Version Date
- 2020-07-06
- Public Version Status
- New
- Public Device Record Key
- cd050fe6-6994-4f8c-a6e5-a7fb26afd5c6
Device Description
4CIS® Riviera Retractor Spreader
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 |
|---|---|---|---|---|
| 63868 | Laparoscopic surgery handle | A hand-held manual surgical instrument intended to be used during laparoscopy to perform a variety of surgical manipulations with various attachable tips/ends; it does not facilitate irrigation or aspiration (suction). It is typically made of metal and/or synthetic material with a straight handle grip. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800033350569 | GS1 |