FDA UDI
In Commercial Distribution
🇺🇸 United States
COMEG MEDICAL
DI: M430S64020041
·
Model: INSUFFLATEUR 20L SOPRO V3 CORDON US
·
SOPRO
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COMEG MEDICAL
- Primary DI
- M430S64020041
- Version / Model
- INSUFFLATEUR 20L SOPRO V3 CORDON US
- Catalog Number
- S_640_2004
- 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
- 6568a2d0-d7dd-4861-b60d-4f0fd22bddf7
Device Description
This device is designed to create pneumoperitoneum (distension of the abdomen with CO2 gas) as part of a diagnostic and/or operative laparoscopy procedure.
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 |
|---|---|---|---|---|
| HIF | Insufflator, Laparoscopic | Obstetrics/Gynecology | 884.1730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16849 | Laparoscopic insufflator | A mains electricity (AC-powered) device designed to distend the peritoneal cavity by filling it with a pressure-limited gas [typically carbon dioxide (CO2)] providing the operator with a space (pneumoperitoneum) in which to perform an examination or surgical intervention. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. Other surgical instruments may be introduced into the peritoneal cavity through other laparoscopic ports. This device may also be referred to as a gas distention system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M430S64020041 | HIBCC |
Customer Contacts
- Phone
- +33556340607
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070783 | 000 |