FDA.reportPublic FDA data

VBAS Extension Arm

Primary DI
00850003228082
Brand
VBAS Extension Arm
Company
DESIGN STANDARDS CORP.
Model
VY1021-01
Catalog number
VY1021-01
Device description
Extension arm for use with the VYCOR Brain Access System (VBAS)
Published
2020-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GDJClamp, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003228082PackageGS11In Commercial Distribution
00850003228075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003228082008500032280828500032280820850003228082
00850003228075008500032280758500032280750850003228075

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system componentA non-patient-contact 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. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
069862878
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003228075VBAS Extension ArmVY1021-01VY1021-012020-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776430993MillenniumAvalign Technologies, Inc.GDJ2026-09-18
00190776426705MillenniumAvalign Technologies, Inc.GDJ2026-08-19
00850088713459PRINCETONPrinceton Medical Group, Inc.GDJ2026-08-14
00850088713466PRINCETONPrinceton Medical Group, Inc.GDJ2026-08-14
00850088713527PRINCETONPrinceton Medical Group, Inc.GDJ2026-08-14
00190776424497MillenniumAvalign Technologies, Inc.GDJ2026-08-07
03701089543286AMPLITUDEAMPLITUDE SASGDJ2026-07-29
00190776422196MillenniumAvalign Technologies, Inc.GDJ2026-07-28
B382SD9055891030Surgical DirectSurgical Direct, Inc.GDJ2026-07-28
B382SD905589105T0Surgical DirectSurgical Direct, Inc.GDJ2026-07-28
00859261006265VBAS Extension ArmVYCOR MEDICAL, INC.GDJ2026-07-27
04059453072832Hermann Medizintechnik GmbHHermann Medizintechnik GmbHGDJ2026-07-13
00850083275150Intrace USAPILOTIS TECH LLCGDJ2026-07-03
B8034906020ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906040ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906060ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906080ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906100ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906180ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906200ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906220ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906240ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
B8034906260ORTHOMEDORTHO-MED, INC.GDJ2026-06-22
04052536085651neon3Ulrich GmbH & Co. KGGDJ2026-06-08
B7685610100Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDJ2025-03-27
B7685610460Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDJ2025-01-10
B7685610500Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDJ2025-01-10
B7685610300Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDJ2024-08-23
B7685614210Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDJ2024-05-31
B7685610440Buxton BioMedicalBUXTON BIOMEDICAL, INC.GDJ2024-04-17