FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AESCULAP
DI: 04038653068630
·
Model: GB043R
·
Aesculap AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AESCULAP
- Primary DI
- 04038653068630
- Version / Model
- GB043R
- Catalog Number
- GB043R
- Company Name
- Aesculap AG
- Labeler DUNS
- 315018218
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-20
- Public Version
- 2
- Public Version Date
- 2021-05-28
- Public Version Status
- Update
- Public Device Record Key
- 8ef240f4-bc82-4a96-906d-95094dc900ac
- Distribution End Date
- 2021-05-03
Device Description
Crushing drum
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 |
|---|---|---|---|---|
| LYS | Bone mill | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18129 | Manual bone mill | A manually-operated, non-patient-contact device intended to be used to grind bone into a slurry or a powder for use as a bone matrix for bone regeneration or bone grafting. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04038653068630 | GS1 |
Customer Contacts
- Phone
- +1(888)229-3002
- [email protected]