FDA UDI
In Commercial Distribution
🇺🇸 United States
Lithotripsy Probe 9FR 54cm
DI: 00817183020110
·
Model: 9-203-0543
·
NORTHGATE TECHNOLOGIES INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Lithotripsy Probe 9FR 54cm
- Primary DI
- 00817183020110
- Version / Model
- 9-203-0543
- Company Name
- NORTHGATE TECHNOLOGIES INC.
- Labeler DUNS
- 627969264
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-13
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 1d6929ba-df99-4ea5-8b68-5a72c05688ba
Device Description
9FR 54cm Lithotripsy Probe for use with Autolith Uro-Touch Lithotripters
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | 876.4480 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60461 | Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-use | A sterile, slender, rod-like device intended to be used as part of an intracorporeal lithotripsy system to transmit shock waves from electrohydraulic or pneumatic sources directly to a calculus in the urinary tract (i.e., kidneys, ureters, and bladder), providing high-speed fragmentation of the calculus in situ. It is typically made of high-grade stainless steel, may be rigid or semi-flexible, and is available in a variety of sizes and lengths. It may be introduced endoscopically through a natural body orifice or a surgically made opening. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817183020110 | GS1 | ||||
| Package | 10817183020117 | GS1 | 3 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130368 | 000 |