FDA UDI
In Commercial Distribution
🇺🇸 United States
INVAC®
DI: 00650551038078
·
Model: 3102-3
·
PMT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- INVAC®
- Primary DI
- 00650551038078
- Version / Model
- 3102-3
- Catalog Number
- 3102-3
- Company Name
- PMT CORPORATION
- Labeler DUNS
- 039576871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- ccfb64f4-ad65-421e-9141-0a37e8c937e6
Device Description
IN-LINE SURGICAL SUCTION CONTROL VALVE, MACRO SURGICAL SIZE - LARGE, BARBED
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
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | General Hospital | 880.6740 | 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 |
|---|---|---|---|---|---|---|
| Primary | 00650551038078 | GS1 |
Customer Contacts
- Phone
- 800-626-5463
- [email protected]
- Phone
- 800-626-5463
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3.75 | Inch | |
| Lumen/Inner Diameter | 0.25 | Inch | |
| Outer Diameter | 0.32 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 58 – 78 Degrees Fahrenheit