FDA UDI
In Commercial Distribution
🇺🇸 United States
Quick Disconnect Endo-Pool
DI: 00801741077067
·
Model: 5536900
·
Davol Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Quick Disconnect Endo-Pool
- Primary DI
- 00801741077067
- Version / Model
- 5536900
- Catalog Number
- 5536900
- Company Name
- Davol Inc.
- Labeler DUNS
- 001191048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-29
- Public Version
- 4
- Public Version Date
- 2023-11-08
- Public Version Status
- Update
- Public Device Record Key
- 4c33036d-f789-4cbd-b9fc-79d5b5d15fc7
Device Description
Quick-Disconnect Endo-Pool Suction Cannula Probe Tip Size: 5mm/33cm
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
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64119 | Surgical irrigation/aspiration cannula, non-illuminating, reusable | An atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), typically to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00801741077067 | GS1 |
Customer Contacts
- Phone
- +1(800)562-0027
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K913999 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5 | Millimeter | |
| Length | 33 | Centimeter |