FDA.reportPublic FDA data

VBAS Extension Arm

Primary DI
00859261006265
Brand
VBAS Extension Arm
Company
VYCOR MEDICAL, INC.
Model
VY1021-01
Catalog number
VY1021-01
Device description
Extension arm for use with the VYCOR Brain Access System (VBAS)
Published
2026-07-27
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

Contact Domains#

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
00850003228075PreviousGS10
00859261006265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003228075008500032280758500032280750850003228075
00859261006265008592610062658592610062650859261006265

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system structural componentA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(561) 558-2020ClientServices@vycormedical.com

Regulatory Flags#

DUNS number
002586317
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
00859261006159Vycor Viewsite Brain Access System with Alignment ClipTC282005AC2021-05-19
00859261006142Vycor Viewsite Brain Access System with Alignment ClipTC282007AC2021-05-19
00859261006166Vycor Viewsite Brain Access System with Alignment ClipTC282003AC2021-05-19
00859261006173Vycor Viewsite Brain Access System with Alignment ClipTC211507AC2021-05-19
00859261006180Vycor Viewsite Brain Access System with Alignment ClipTC211505AC2021-05-19
00859261006197Vycor Viewsite Brain Access System with Alignment ClipTC211503AC2021-05-19
00859261006203Vycor Viewsite Brain Access System with Alignment ClipTC171107AC2021-05-19
00859261006210Vycor Viewsite Brain Access System with Alignment ClipTC171105AC2021-05-19
00859261006227Vycor Viewsite Brain Access System with Alignment ClipTC171103AC2021-05-19
00859261006234Vycor Viewsite Brain Access System with Alignment ClipTC120807AC2021-05-19
00859261006241Vycor Viewsite Brain Access System with Alignment ClipTC120805AC2021-05-19
00859261006258Vycor Viewsite Brain Access System with Alignment ClipTC120803AC2021-05-19
00859261006005Vycor Viewsite Brain Access SystemTC0604052017-06-21
00859261006012Vycor Viewsite Brain Access SystemTC0604072017-06-21
00859261006029Vycor Viewsite Brain Access SystemTC1208032017-06-21
00859261006036Vycor Viewsite Brain Access SystemTC1208052017-06-21
00859261006043Vycor Viewsite Brain Access SystemTC1208072017-06-21
00859261006067Vycor Viewsite Brain Access SystemTC1711052017-01-30
00859261006081Vycor Viewsite Brain Access SystemTC2115032017-06-21
00859261006098Vycor Viewsite Brain Access SystemTC2115052017-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701089543286AMPLITUDEAMPLITUDE SASGDJ2026-07-29
00190776422196MillenniumAvalign Technologies, Inc.GDJ2026-07-28
B382SD9055891030Surgical DirectSurgical Direct, Inc.GDJ2026-07-28
B382SD905589105T0Surgical DirectSurgical Direct, Inc.GDJ2026-07-28
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
10849771050374NAKEY SURGICAL, INC.GDJ2023-03-31
G25003048090Backhaus Towel Forceps 9cmN S SURGICAL COMPANYGDJ2023-01-31
G25003048110Backhaus Towel Forceps 11cmN S SURGICAL COMPANYGDJ2023-01-31
G25003048130Backhaus Towel Forceps 13cmN S SURGICAL COMPANYGDJ2023-01-31
10849771050381NAKEY SURGICAL, INC.GDJ2023-01-26
10849771050398NAKEY SURGICAL, INC.GDJ2023-01-26
10886982311146NASynthes GmbHGDJ2022-11-29
10886982311153NASynthes GmbHGDJ2022-11-29
10886982311160NASynthes GmbHGDJ2022-11-29
10886982311177NASynthes GmbHGDJ2022-11-29
ESOT001972NAS & T AGGDJ2022-09-15
ESOT001982NAS & T AGGDJ2022-09-15
ESOT002452NAS & T AGGDJ2022-09-15