FDA.reportPublic FDA data

VERASENSE

Primary DI
00816818020808
Brand
VERASENSE
Company
ORTHOSENSOR INC
Model
VERASENSE for Smith & Nephew Legion PS size 3-4
Catalog number
SNN-LGNPS34
Published
2017-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ONNIntraoperative Orthopedic Joint Assessment Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONNIntraoperative Orthopedic Joint Assessment AidNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816818020808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816818020808008168180208088168180208080816818020808

GMDN Terms#

Term, Definition table
TermDefinition
Arthroplasty force sensorA sterile, battery-powered electronic device designed for use during arthroplasty to facilitate assessment of bone resection lines and/or size or positioning of prosthesis components to be implanted. It is dedicated to a specific joint or type of prosthesis (e.g., total knee, reverse shoulder) and consists of a transducer pad for insertion between opposing joint surfaces. It may have an integrated digital display or wirelessly connect to an external display unit. It is typically available in various sizes and as a left or right version. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure47 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius37 Degrees Celsius
Storage Environment Atmospheric Pressure36 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005788130
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816818021478VERASENSE for Zimmer Biomet PersonaVERASENSE for Zimmer Biomet Persona CR C-D/3-9 LefZBH-PSNCRCD39-L2020-11-18
00816818021485VERASENSE for Zimmer Biomet PersonaVERASENSE for Zimmer Biomet Persona CR C-D/3-9 RigZBH-PSNCRCD39-R2020-11-18
00816818021492VERASENSE for Zimmer Biomet PersonaVERASENSE for Zimmer Biomet Persona CR E-F/3-11 LeZBH-PSNCREF311-L2020-11-18
00816818021508VERASENSE for Zimmer Biomet PersonaVERASENSE for Zimmer Biomet Persona CR E-F/3-11 RiZBH-PSNCREF311-R2020-11-18
00816818021515VERASENSE for Zimmer Biomet PersonaVERASENSE for Zimmer Biomet Persona CR G-H/7-12 LeZBH-PSNCRGH712-L2020-11-18
00816818021522VERASENSE for Zimmer Biomet PersonaVERASENSE for Zimmer Biomet Persona CR G-H/7-12 RiZBH-PSNCRGH712-R2020-11-18
00816818021539VERASENSE for Stryker TriathlonVERASENSE for Stryker Triathlon CR Size 2SYK-TRCR022020-11-18
00816818021546VERASENSE for Stryker TriathlonVERASENSE for Stryker Triathlon CR Size 3SYK-TRCR032020-11-18
00816818021553VERASENSE for Stryker TriathlonVERASENSE for Stryker Triathlon CR Size 4SYK-TRCR042020-11-18
00816818021560VERASENSE for Stryker TriathlonVERASENSE for Stryker Triathlon CR Size 5SYK-TRCR052020-11-18
00816818021577VERASENSE for Stryker TriathlonVERASENSE for Stryker Triathlon CR Size 6SYK-TRCR062020-11-18
00816818021584VERASENSE for Stryker TriathlonVERASENSE for Stryker Triathlon CR Size 7SYK-TRCR072020-11-18
00816818022130VERASENSE for Exactech Equinoxe ReverseVERASENSE for Exactech Equinoxe Reverse Size 38 mmEXC-EQRV38-US2020-11-18
00816818022147VERASENSE for Exactech Equinoxe ReverseVERASENSE for Exactech Equinoxe Reverse Size 42 mmEXC-EQRV42-US2020-11-18
07613327581843VERASENSE Software Application5.6.1.13805000-VRSE2022-08-24
00816818022536LinkStation MINILinkStation MINI05000-001-B2021-04-28
00816818022635Linkstation MINI Evaluation KitLinkstation MINI Evaluation Kit05000-500-B2021-04-28
00816818021652VERASENSEVERASENSE for Smith & Nephew Legion PS size 5-6SNN-LGNPS562020-12-31
00816818021669VERASENSEVERASENSE for Smith & Nephew Legion PS size 7-8SNN-LGNPS782020-12-31
00816818021676VERASENSEVERASENSE for Smith & Nephew Legion CR size 1-2SNN-LGNCR122020-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810832032489LanternOrthalign, Inc.ONN2025-12-12
00810832032243LanternOrthalign, Inc.ONN2025-11-19
00810832031994LanternOrthalign, Inc.ONN2025-09-12
00810832032311LanternOrthalign, Inc.ONN2025-05-06
00810832032335LanternOrthalign, Inc.ONN2025-05-06
00810832032229Lantern Orthalign, Inc.ONN2025-04-24
05065012584493Quadsense ProEVENTUM ORTHOPAEDICS LTDONN2025-04-04
05065012584158QuadsenseEVENTUM ORTHOPAEDICS LTDONN2025-01-22
05065012584233Dongle AssemblyEVENTUM ORTHOPAEDICS LTDONN2025-01-22
05065012584516Panel PCEVENTUM ORTHOPAEDICS LTDONN2025-01-22
05065012584523TrollyEVENTUM ORTHOPAEDICS LTDONN2025-01-22
00810832031895Lantern Orthalign, Inc.ONN2024-12-13
00810832031901LanternOrthalign, Inc.ONN2024-12-13
00810832031918LanternOrthalign, Inc.ONN2024-12-13
00810832031925LanternOrthalign, Inc.ONN2024-12-13
00810832031932LanternOrthalign, Inc.ONN2024-12-13
00810832032014LanternOrthalign, Inc.ONN2024-12-13
00810832032021Lantern Orthalign, Inc.ONN2024-12-13
00810832032038Lantern Orthalign, Inc.ONN2024-12-13
00810832032045LanternOrthalign, Inc.ONN2024-12-13
00810832032069LanternOrthalign, Inc.ONN2024-12-13
00810832032076Lantern Orthalign, Inc.ONN2024-12-13
00810832032106Lantern Orthalign, Inc.ONN2024-12-13
00810832032120LanternOrthalign, Inc.ONN2024-12-13
00810832032137LanternOrthalign, Inc.ONN2024-12-13
00810832032144Lantern Surgical AssistantOrthalign, Inc.ONN2024-12-13
00810832032151LanternOrthalign, Inc.ONN2024-12-13
00810832032168LanternOrthalign, Inc.ONN2024-12-13
00810832032199LanternOrthalign, Inc.ONN2024-12-13