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
GDJ Clamp, Surgical, General & Plastic Surgery

GMDN Terms

Code Name
64146 Surgical instrument assist arm system structural component

Identifiers

Type ID
Package 00850003228082
Primary 00850003228075