FDA.reportPublic FDA data

COAPTIUM® Selector

Primary DI
03760279380377
Brand
COAPTIUM® Selector
Company
TISSIUM
Model
NCOSE0001
Catalog number
NCOSE0001
Published
2025-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAOInstrument, Surgical, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760279380384PackageGS120In Commercial Distribution
03760279380377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760279380384037602793803843760279380384
03760279380377037602793803773760279380377

GMDN Terms#

Term, Definition table
TermDefinition
Medical ruler, single-useA small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be bendable to fit on the measured surfaces. It is not an implant sizer/prosthesis trial of a predetermined size, nor is it dedicated to wound measurements. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1.888.847.7486customercare@tissium.com

Regulatory Flags#

DUNS number
265137228
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760279380070COAPTIUM® ConnectNCOCO1510NCOCO15102025-09-22
03760279380087COAPTIUM® ConnectNCOCO1575NCOCO15752025-09-22
03760279380094COAPTIUM® ConnectNCOCO2010NCOCO20102025-09-22
03760279380100COAPTIUM® ConnectNCOCO2075NCOCO20752025-09-22
03760279380117COAPTIUM® ConnectNCOCO3010NCOCO30102025-09-22
03760279380124COAPTIUM® ConnectNCOCO3015NCOCO30152025-09-22
03760279380131COAPTIUM® ConnectNCOCO3075NCOCO30752025-09-22
03760279380148COAPTIUM® ConnectNCOCO4010NCOCO40102025-09-22
03760279380155COAPTIUM® ConnectNCOCO4015NCOCO40152025-09-22
03760279380162COAPTIUM® ConnectNCOCO4075NCOCO40752025-09-22
03760279380179COAPTIUM® ConnectNCOCO5010NCOCO50102025-09-22
03760279380186COAPTIUM® ConnectNCOCO5015NCOCO50152025-09-22
03760279380193COAPTIUM® ConnectNCOCO5075NCOCO50752025-09-22
03760279380209COAPTIUM® ConnectNCOCO6010NCOCO60102025-09-22
03760279380216COAPTIUM® ConnectNCOCO60152025-09-22
03760279380223COAPTIUM® ConnectNCOCO6075NCOCO60752025-09-22
03760279380063TISSIUM® LIGHTLTIOP0001LTIOP00012025-09-20
03760279380056TISSIUM® LIGHTLTIOP0001LTIOP00012025-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G586N93065370Novo SurgicalNOVO SURGICAL, INC.HAO2024-02-22
G586N93065380Novo SurgicalNOVO SURGICAL, INC.HAO2024-02-22
G28435301ScrewdriverNeurovention LLCHAO2022-06-21
07613327262322XIAStryker CorporationHAO2019-11-21
07613327264432XIA 4.5Stryker CorporationHAO2019-11-21
07613327264951XIA 3Stryker CorporationHAO2019-11-21
07613327271447OASYSStryker CorporationHAO2019-11-21
07613327276176RADIUSStryker CorporationHAO2019-11-21
07613327263787RELIANCE LITeStryker CorporationHAO2019-11-20
07613327263923RELIANCE LITeStryker CorporationHAO2019-11-20
07613327265897RELIANCE LITeStryker CorporationHAO2019-11-20
07613327265910RELIANCE LITeStryker CorporationHAO2019-11-20
07613327265934RELIANCE LITeStryker CorporationHAO2019-11-20
07613327266016RELIANCE LITeStryker CorporationHAO2019-11-20
10381780167778Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-10-23
10381780222682Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-09-12
10381780223276Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-09-12
10381780223283Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-09-12
10381780223368Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-09-12
10381780223429Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-09-12
10381780180647Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780180654Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780180661Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780180678Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780180722Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780180920Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780180937Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780188742Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780188759Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09
10381780223351Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAO2018-04-09