FDA UDI
In Commercial Distribution
🇺🇸 United States
Dornier MedTech
DI: 00810116023455
·
Model: Holmium 270um 3M Fiber 3ST 10X Use- LATAM Non-RFID Reusable
·
DORNIER MEDTECH AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Dornier MedTech
- Primary DI
- 00810116023455
- Version / Model
- Holmium 270um 3M Fiber 3ST 10X Use- LATAM Non-RFID Reusable
- Catalog Number
- DUR270R
- Company Name
- DORNIER MEDTECH AMERICA, INC.
- Labeler DUNS
- 130789944
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-26
- Public Version
- 1
- Public Version Date
- 2023-07-04
- Public Version Status
- New
- Public Device Record Key
- 096e9a8e-43aa-4cf3-9375-2cbc151e9196
Device Description
Holmium 270um 3M Fiber 3ST 10X Use- LATAM Non-RFID Reusable
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
- 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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36037 | Laser lithotripsy system | An assembly of devices consisting of a specialized ureteroscope, a laser resistant catheter, and a dedicated laser designed for the intracorporeal disintegration of ureteral stones (calculi). The assembly transmits the laser energy to the stone(s) which fragment. The debris may be removed forcefully or passed out later by natural means. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810116023452 | GS1 | Box | 3 | In Commercial Distribution | |
| Primary | 00810116023455 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123385 | 000 |