FDA UDI
In Commercial Distribution
🇺🇸 United States
Dornier MedTech
DI: 00810116024070
·
Model: AXIS II Clerix Suction URS
·
DORNIER MEDTECH AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Dornier MedTech
- Primary DI
- 00810116024070
- Version / Model
- AXIS II Clerix Suction URS
- Catalog Number
- AX20419
- Company Name
- DORNIER MEDTECH AMERICA, INC.
- Labeler DUNS
- 130789944
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-26
- Public Version
- 1
- Public Version Date
- 2026-04-03
- Public Version Status
- New
- Public Device Record Key
- c41b7ebd-888d-4071-8ffd-cfd6ee6c68f0
Device Description
2.7mm Diameter (8.1Fr), 1.2mm (3.6Fr) Working Suction Channel
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
- 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 |
|---|---|---|---|---|
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64074 | Flexible video ureteroscope, single-use | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder). It is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are typically transmitted by a video system with a high definition complementary metal oxide semiconductor (CMOS) chip at the distal end with images showing on a monitor. This device is commonly used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810116024087 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 00810116024070 | GS1 | ||||
| Package | 10810116024084 | GS1 | 20 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252806 | 000 |