FDA UDI
In Commercial Distribution
🇺🇸 United States
Dornier MedTech
DI: 00810116023943
·
Model: Dornier Falcon
·
DORNIER MEDTECH AMERICA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Dornier MedTech
- Primary DI
- 00810116023943
- Version / Model
- Dornier Falcon
- Catalog Number
- IVX-GF1-1808A
- Company Name
- DORNIER MEDTECH AMERICA, INC.
- Labeler DUNS
- 130789944
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-17
- Public Version
- 1
- Public Version Date
- 2026-04-27
- Public Version Status
- New
- Public Device Record Key
- 7cc13c21-5c7e-4603-acf1-f0bd92e48065
Device Description
Falcon Single Use Grasping Forceps
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
- 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 |
|---|---|---|---|---|
| PTS | Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46685 | Flexible endoscopic stone-retrieval forceps, single-use | A flexible manual device intended to be inserted through the working channel of a compatible flexible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure. It is typically a flexible metal coil or plastic tube whose distal end is equipped with a pair of thin grasping claws in which the stone is seized and held for extraction. The claws are operated by a control handle at the proximal end of the instrument. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810116023950 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00810116023943 | GS1 | ||||
| Package | 10810116023940 | GS1 | 40 | In Commercial Distribution |