FDA UDI
In Commercial Distribution
🇺🇸 United States
MICRO-LINE
DI: 04038653068890
·
Model: GB128R
·
Aesculap AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MICRO-LINE
- Primary DI
- 04038653068890
- Version / Model
- GB128R
- Catalog Number
- GB128R
- Company Name
- Aesculap AG
- Labeler DUNS
- 315018218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-20
- Public Version
- 1
- Public Version Date
- 2020-04-28
- Public Version Status
- New
- Public Device Record Key
- c9ab88b4-5d86-491f-a009-fe31a7c3458f
Device Description
micro-Line sagittal saw
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 |
|---|---|---|---|---|
| GFA | BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43665 | Sawing power tool attachment, oscillating | A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform an oscillating sawing function when an oscillating saw blade is inserted. This attachment is designed with the cutting teeth arranged in an arc or on a flat plane at its distal end; the teeth are at a 90° angle to its shaft and it cuts when it is moved in a rapid oscillating motion. It is typically made of high-grade stainless steel and synthetic materials and of the macro design. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04038653068890 | GS1 |
Customer Contacts
- Phone
- +1(800)282-9000
- [email protected]