FDA UDI
In Commercial Distribution
🇺🇸 United States
Meridian Perforator
DI: EADEPER711SP1
·
Model: alpha
·
adeor Medical AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Meridian Perforator
- Primary DI
- EADEPER711SP1
- Version / Model
- alpha
- Catalog Number
- PER 7-11-SP
- Company Name
- adeor Medical AG
- Labeler DUNS
- 341188943
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-11
- Public Version
- 5
- Public Version Date
- 2023-05-26
- Public Version Status
- Update
- Public Device Record Key
- a61842d3-aa8c-4aac-af35-46a9ee877174
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
- 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 |
|---|---|---|---|---|
| HBF | Drills, Burrs, Trephines & Accessories (Compound, Powered) | Neurology | 882.4305 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46277 | Automatic cranial perforator, single-use | A sterile, metallic rotary endpiece designed to cut a circular section, or sections, of the skull vault (calvarium) to provide access to the interior for diagnostic/therapeutic purposes or for the removal of a bone flap for brain surgery. It typically consists of two coaxial drill shafts (one rotating inside the other), a drive shank that enables connection to a powered (either electrical or pneumatic) handpiece, and a built-in clutch mechanism. The inner drill shaft extends slightly beyond the outer cutter in such a way that when the inner drill shafts penetrates the inner table of the skull the clutch mechanism disengages. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EADEPER711SP1 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121253 | 000 |