FDA UDI
In Commercial Distribution
🇺🇸 United States
ACCULAN 3TI
DI: 04038653460656
·
Model: GB630R
·
Aesculap AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ACCULAN 3TI
- Primary DI
- 04038653460656
- Version / Model
- GB630R
- Catalog Number
- GB630R
- Company Name
- Aesculap AG
- Labeler DUNS
- 315018218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-29
- Public Version
- 1
- Public Version Date
- 2022-08-08
- Public Version Status
- New
- Public Device Record Key
- 47fd150e-2cc8-4221-9a58-5c441c4c71a9
Device Description
Acculan 3Ti drill attachment
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
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66243 | Bone/joint surgical power tool motorized handpiece/set, electric, reusable | An electrically-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 an electric 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 may include a rechargeable battery or a control unit; 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 | 04038653460656 | GS1 |
Customer Contacts
- Phone
- +1(888)229-3002
- [email protected]