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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
DM exempt
false
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
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
03760279380063TISSIUM® LIGHTLTIOP0001LTIOP00012025-09-20
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
03760279380056TISSIUM® LIGHTLTIOP0001LTIOP00012025-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995301934V. MuellerSteris CorporationHAO2026-10-21
00724995301958V. MuellerSteris CorporationHAO2026-10-21
00724995301972V. MuellerSteris CorporationHAO2026-10-21
00724995301989V. MuellerSteris CorporationHAO2026-10-21
00724995301996V. MuellerSteris CorporationHAO2026-10-21
00724995302214V. MuellerSTERIS Deutschland GmbHHAO2026-10-21
00724995303761V. MuellerSTERIS Deutschland GmbHHAO2026-10-21
00724995303853V. MuellerSTERIS Deutschland GmbHHAO2026-10-21
00724995303860V. MuellerSTERIS Deutschland GmbHHAO2026-10-21
04058749126471NAFehling Instruments GmbH & Co. KGHAO2026-10-12
00190776436551MilleniumAvalign Technologies, Inc.HAO2026-10-08
00190776436568MilleniumAvalign Technologies, Inc.HAO2026-10-08
00190776436575MilleniumAvalign Technologies, Inc.HAO2026-10-08
00190776436582MilleniumAvalign Technologies, Inc.HAO2026-10-08
00190776434427MillenniumAvalign Technologies, Inc.HAO2026-10-07
00190776434434MillenniumAvalign Technologies, Inc.HAO2026-10-07
00190776434342MillenniumAvalign Technologies, Inc.HAO2026-10-06
00199150032402SenSight™MEDTRONIC, INC.HAO2026-09-28
00199150032426SenSight™MEDTRONIC, INC.HAO2026-09-28
00724995303884V. MuellerSTERIS Deutschland GmbHHAO2026-09-25
04058749076042NAFehling Instruments GmbH & Co. KGHAO2026-09-21
00190776429126MillenniumAvalign Technologies, Inc.HAO2026-09-04
00190776423964MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776423995MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428068MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428075MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428082MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428099MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428105MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428112MillenniumAvalign Technologies, Inc.HAO2026-08-27