FDA.reportPublic FDA data

ToeJack Bunion Correction System

Primary DI
00810135965088
Brand
ToeJack Bunion Correction System
Company
NVision Biomedical Technologies, Inc.
Model
TJB-1000C-104
Device description
MIS Bunion Implant Caddy Base
Published
2026-07-29
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
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810135965088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810135965088008101359650888101359650880810135965088

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 210-598-5648anikajosephsmith@nvisionbiomed.com

Regulatory Flags#

DUNS number
047486041
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00810005663762ToejackTB-30-20L2026-07-29
00810005663779ToejackTB-30-22L2026-07-29
00810005665711ToejackTB-30-18L2026-07-29
00810005668828TrigonTB-30-18N2026-07-29
00810005668835ToeJackTB-30-20N2026-07-29
00810005668842ToejackTB-30-22N2026-07-29
00810135961196ToeJackTJB-30-302026-07-29
00810135961202ToejackTJB-1000T-D30S2026-07-29
00810135961219ToejackTJB-1000T-D30C2026-07-29
00810135961226ToejackTJB-1000T-T8CI2026-07-29
00810135961233ToejackTJB-1001T-DPG2026-07-29
00810135961257ToejackTJB-1001T-SG032026-07-29
00810135961288ToejackTJB-1000T-PKS2026-07-29
00810135961769ToejackTJB-30-14HL2026-07-29
00810135961776ToejackTJB-30-16HL2026-07-29
00810135961783ToejackTJB-30-18HL2026-07-29
00810135961790ToejackTJB-30-20HL2026-07-29
00810135961806ToejackTJB-30-22HL2026-07-29
00810135963121ToeJack Bunion Correction SystemTJB-1000C-1052026-07-29
00810135965163ToejackTJB-1000C-1072026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956379084CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956421462CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956454989CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956468399CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956484795CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956505919CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956507678CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956507975CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956509061CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956509108CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956514423CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956519404CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956530003CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956530775CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956533783CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956533844CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956538696CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956544246CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956545137CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956545595CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956547612CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956551732CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956551756CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956551770CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956552814CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956553668CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956553804CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956555259CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956555471CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956555648CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04