FDA UDI
In Commercial Distribution
🇺🇸 United States
X-Stream
DI: 00801741010095
·
Model: 5552002
·
Davol Inc.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- X-Stream
- Primary DI
- 00801741010095
- Version / Model
- 5552002
- Catalog Number
- 5552002
- Company Name
- Davol Inc.
- Labeler DUNS
- 001191048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-12-23
- Public Version
- 3
- Public Version Date
- 2023-11-08
- Public Version Status
- Update
- Public Device Record Key
- 251c1c72-4fd6-45e2-a1ee-63f19643832d
Device Description
X-Stream Laparoscopic Irrigation Tubing Set with Nezhat-Dorsey Trumpet Valve, 5mm x 33cm Probe Tip with Holes and Cojoined Suction/Irrigation Tubing
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HET | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) | Obstetrics/Gynecology | 884.1720 | 2 |
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47625 | Surgical irrigation/aspiration tubing set | A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741010092 | GS1 | BX | 5 | In Commercial Distribution | |
| Primary | 00801741010095 | GS1 | ||||
| Package | 20801741010099 | GS1 | CA | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)562-0027
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 33 | Centimeter | |
| Circumference | 5 | Millimeter |