FDA UDI
In Commercial Distribution
🇺🇸 United States
VBAS Extension Arm
DI: 00850003228075
·
Model: VY1021-01
·
DESIGN STANDARDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- VBAS Extension Arm
- Primary DI
- 00850003228075
- Version / Model
- VY1021-01
- Catalog Number
- VY1021-01
- Company Name
- DESIGN STANDARDS CORP.
- Labeler DUNS
- 069862878
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-17
- Public Version
- 2
- Public Version Date
- 2021-05-10
- Public Version Status
- Update
- Public Device Record Key
- ce1b61a5-b030-41ca-aac1-6b08c940c60c
Device Description
Extension arm for use with the VYCOR Brain Access System (VBAS)
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
- 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 |
|---|---|---|---|---|
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64146 | Surgical instrument assist arm system structural component | A connecting component of a surgical instrument assist arm system intended to be integrated as part of the structural assembly of the arm. It is a structural component (not a repair tool) and may be in the form of an arm piece/rod, base unit, clamp, actuator, or instrument holding component; it is not intended to be used as the distal tissue interfacing instrument. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850003228082 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00850003228075 | GS1 |