FDA UDI
In Commercial Distribution
🇺🇸 United States
Perforator Motor
DI: 07630055507860
·
Model: 362641
·
Bien-Air Surgery SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Perforator Motor
- Primary DI
- 07630055507860
- Version / Model
- 362641
- Catalog Number
- 1601133-001
- Company Name
- Bien-Air Surgery SA
- Labeler DUNS
- 481597719
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-22
- Public Version
- 1
- Public Version Date
- 2023-03-02
- Public Version Status
- New
- Public Device Record Key
- 6a7f8dc9-39cf-4b6f-98ec-baa6bb272851
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
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Ear, Nose, Throat | 874.4250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46279 | Manual cranial rotary handpiece, reusable | A manually-powered, hand-held, surgical device intended to be used to remove circular sections of the skull vault (calvarium) to provide access to the interior for diagnosis (e.g., the insertion of a neuroscope), or treatments [e.g., to alleviate intracranial pressure (ICP)], or for the removal of a bone flap for brain surgery. It is typically a drill brace or a housing containing bevelled and/or straight teethed gears rotated via a side handle, and a Jacobs chuck or gripping collet to attach an exchangeable rotating endpiece (e.g., a cranial drill, bur, trephine or perforator). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17630055507867 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 07630055507860 | GS1 |