FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ACCULAN II
DI: 04038653295265
·
Model: GA644
·
Aesculap AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ACCULAN II
- Primary DI
- 04038653295265
- Version / Model
- GA644
- Catalog Number
- GA644
- Company Name
- Aesculap AG
- Labeler DUNS
- 315018218
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-23
- Public Version
- 2
- Public Version Date
- 2021-05-28
- Public Version Status
- Update
- Public Device Record Key
- e53bbafe-0ac0-4582-8148-aa0fe567fa70
- Distribution End Date
- 2021-05-03
Device Description
ACCULAN II CHANGING FUNNEL SHORT
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| GEY | MOTOR, SURGICAL INSTRUMENT, AC-POWERED | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44641 | Multi-purpose surgical power tool system, rechargeable battery-powered | An assembly of devices designed to resect bones and tough tissues (e.g., cartilage, ligaments) during a surgical procedure; it is not dedicated to a specific clinical application. It includes a rechargeable battery pack/control unit which supplies low-voltage electricity, motors/handpieces/power tool attachments, and a variety of tools (e.g., drill bits, burs, saw blades, screwdriver bits, and guide wires); it is not intended to be connected to mains power. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04038653295265 | GS1 |
Customer Contacts
- Phone
- +1(888)229-3002
- [email protected]