FDA UDI
In Commercial Distribution
🇺🇸 United States
COMEG MEDICAL
DI: M430S67000021
·
Model: S670 - IRRIGATEUR - SOPRO - US
·
SOPRO
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COMEG MEDICAL
- Primary DI
- M430S67000021
- Version / Model
- S670 - IRRIGATEUR - SOPRO - US
- Catalog Number
- S_670_0002
- Company Name
- SOPRO
- Labeler DUNS
- 264205501
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 294c0014-b435-464c-a9d5-a95ccc47298a
Device Description
This machine controls the introduction of liquid into an articulation during arthroscopic surgery. It can be used for diagnostic purposes as well as arthroscopic surgery and enables intra-articular distension to be maintained and rinsing to be carried out.
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRX | Arthroscope | Orthopedic | 888.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36023 | Endoscopic irrigation/aspiration pump | A mains electricity (AC-powered) device intended to generate positive and/or negative pressures, to irrigate and/or aspirate a body cavity or lumen with sterile fluid (e.g., saline water) through an endoscope typically to facilitate observation of a site with an endoscope (e.g., during arthroscopy), and/or to keep clear the working channel of an endoscope or lumen of a catheter. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M430S67000021 | HIBCC |
Customer Contacts
- Phone
- +33556340607
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080122 | 000 |