FDA.report

Titan™

Primary DI
10381780489153
Brand
Titan™
Company
Ascension Orthopedics, Inc.
Model
CSA-0961-02
Catalog number
CSA-0961-02
Device description
Instrument Tray Insert Assembly
Published
2018-11-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780489153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178048915310381780489153

GMDN Terms

TermDefinition
Instrument trayA container intended to provide a suitable platform for placing/containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags

DUNS number
942377524
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
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

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M269IMP89000MT1Movement®IMP-890-00MTIMP-890-00MT2017-09-05
M269IMP89000PP1Movement®IMP-890-00PPIMP-890-00PP2017-09-05
10381780355922Titan™IMP-0926-030-00AIMP-0926-030-00A2018-10-04
10381780355939Titan™IMP-0926-030-01AIMP-0926-030-01A2018-10-04
10381780355946Titan™IMP-0926-030-02AIMP-0926-030-02A2018-10-04
10381780355953Titan™IMP-0926-030-03AIMP-0926-030-03A2018-10-04
10381780355960Titan™IMH-0926-000IMH-0926-0002018-10-04
M268TIWEDGEINSTP1TiWedgeTMTIWEDGEINSTP2016-08-15
M269AW32051CAPTURE™AW-3205AW32052017-08-30
10381780123026CAPTURE™ High Torque Screw SystemCSS500000625WTCSS500000625WT2017-10-09
10381780123033CAPTURE™ High Torque Screw SystemCSS500000630WTCSS500000630WT2017-10-09
10381780123040CAPTURE™ High Torque Screw SystemCSS500000640WTCSS500000640WT2017-10-09
10381780123057CAPTURE™ High Torque Screw SystemCSS500000650WTCSS500000650WT2017-10-09
10381780123064CAPTURE™ High Torque Screw SystemCSS500000670WTCSS500000670WT2017-10-09
M26922286111Integra®222861122286112017-08-30
M26922378111Integra®223781122378112017-08-30
M269AI11031CAPTURE™AI-1103AI11032017-08-30
M269AI31011CAPTURE™AI-3101AI31012017-08-30
M269AI32011CAPTURE™AI-3201AI32012017-08-30
M269AI32021CAPTURE™AI-3202AI32022017-08-30

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