FDA UDI
In Commercial Distribution
🇺🇸 United States
VELOCITY ALPHA ™
DI: 04251388924105
·
Model: Wall-Tubing, open-end, (MR conditional)
·
adeor Medical AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VELOCITY ALPHA ™
- Primary DI
- 04251388924105
- Version / Model
- Wall-Tubing, open-end, (MR conditional)
- Catalog Number
- ZMW-121
- Company Name
- adeor Medical AG
- Labeler DUNS
- 341188943
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-30
- Public Version
- 1
- Public Version Date
- 2026-04-07
- Public Version Status
- New
- Public Device Record Key
- e46e5a6c-a97b-4596-9128-bd6a3d4fee9f
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HBB | Motor, Drill, Pneumatic | Neurology | 882.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37869 | Pneumatic surgical power tool hose | A single- or double-lumen (coaxial) tube in a straight or spiral design intended to be used to conduct compressed surgical-grade air or nitrogen (N2) gas from a gas source, usually the central medical gas supply system, to a surgical drilling system or sawing system handpiece or motor to supply it with power. The device is usually from 2 to 5 meters in length and is commonly designed according to ISO5359. The coaxial types have a double tube (inner and outer tubing) to facilitate the removal of the exhaust gases. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04251388924105 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K253772 | 000 |