FDA UDI
In Commercial Distribution
🇺🇸 United States
LithAssist
DI: 00827002238107
·
Model: G23810
·
COOK INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LithAssist
- Primary DI
- 00827002238107
- Version / Model
- G23810
- Catalog Number
- LA-116038
- Company Name
- COOK INCORPORATED
- Labeler DUNS
- 042823948
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- 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
- 1d460b2a-8fc2-44eb-b000-869c1aa808c5
Device Description
LithAssist Suction Control for Laser Lithotripsy
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KQT | EVACUATOR, GASTRO-UROLOGY | Gastroenterology, Urology | 876.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60705 | Laser lithotripsy fibre/suction guide | A sterile device intended to be inserted through the working channel of a rigid nephroscope during laser lithotripsy to function as a channel for insertion of the laser fibre of an endotherapy laser beam guide, and for removal of debris (e.g., fluid, calculi fragments) when connected to a vacuum source. It typically consists of a thin hollow tube inserted through a handle, which enable entry of the laser fibre and connection to vacuum tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00827002238107 | GS1 |
Customer Contacts
- Phone
- +1(812)330-5494
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dark, dry, cool place.