FDA UDI
In Commercial Distribution
🇺🇸 United States
FLOVAC
DI: 30653405034753
·
Model: 60-6005-505
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- FLOVAC
- Primary DI
- 30653405034753
- Version / Model
- 60-6005-505
- Catalog Number
- 60-6005-505
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- a72283cf-73f3-44b3-9247-fdb497d86e09
Device Description
FLOVAC HANDCONTROLLED SUCTION/IRRIGATION
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
- No
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57823 | Surgical irrigation/aspiration handpiece control valve | A sterile device designed as a push-button valve that is inserted into the control valve seat of a reusable surgical irrigation/aspiration handpiece and when activated by the operator will interrupt the aspiration (suction) and activate the irrigation function (the fluid flow) of the handpiece/system. This provides a high level of hygiene as this device is removed after each application and discarded negating complicated and time-consuming cleaning procedures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20653405034756 | GS1 | CASE | 10 | In Commercial Distribution | |
| Primary | 30653405034753 | GS1 | ||||
| Unit of Use | 00653405034752 | GS1 |
Customer Contacts
- Phone
- +1(800)237-0169
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 32 Degrees Celsius