FDA UDI
In Commercial Distribution
🇺🇸 United States
AESCULAP
DI: 04038653074518
·
Model: GD397R
·
Aesculap AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- AESCULAP
- Primary DI
- 04038653074518
- Version / Model
- GD397R
- Catalog Number
- GD397R
- Company Name
- Aesculap AG
- Labeler DUNS
- 315018218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-06-07
- Public Version
- 3
- Public Version Date
- 2021-01-22
- Public Version Status
- Update
- Public Device Record Key
- 0cfedeed-a886-45bc-aa6b-8ebc4b8aca02
Device Description
SAW BLADE F/GD307 25/12/0.3/0.3MM
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 44984 | Surgical saw blade, oscillating, reusable | A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge and designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at its distal end to cut in a rapid oscillating (circular/arc-shaped) motion; it is not intended to perform a sagittal motion. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04038653074518 | GS1 | ||||
| Unit of Use | 04038653339341 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]