FDA UDI
In Commercial Distribution
🇺🇸 United States
AESCULAP
DI: 04046963336264
·
Model: GA742R
·
Aesculap AG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AESCULAP
- Primary DI
- 04046963336264
- Version / Model
- GA742R
- Catalog Number
- GA742R
- Company Name
- Aesculap AG
- Labeler DUNS
- 315018218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 6
- Public Version Date
- 2023-07-18
- Public Version Status
- Update
- Public Device Record Key
- dc1dc292-9d01-4765-81d5-0430ad654cd4
Device Description
HiLAN perforator driver
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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | General, Plastic Surgery | 878.4820 | 1 |
| HBB | MOTOR, DRILL, PNEUMATIC | Neurology | 882.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58189 | Bone/joint surgical power tool motorized handpiece/set, pneumatic | A pneumatically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a non-dental surgical procedure. It includes a pneumatic motor and one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect the endpieces, and typically includes a pneumatic hose; the endpieces are not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046963336264 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]