FDA.reportPublic FDA data

Hexanium® TLIF

Primary DI
03663136033273
Brand
Hexanium® TLIF
Company
SPINEVISION
Model
TL3-TRAY113
Device description
Ti TLIF Instruments Tray
Published
2018-05-22
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03663136033273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663136033273036631360332733663136033273

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
+33153332525corp.quality@spinevision.com

Regulatory Flags#

DUNS number
390377518
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03663136009308Hexanium® ACIFAC2-A012-M11L2025-02-20
03663136009315Hexanium® ACIFAC2-A012-M09L2025-02-20
03663136009322Hexanium® ACIFAC2-A012-M07L2025-02-20
03663136009339Hexanium® ACIFAC2-A012-M05L2025-02-20
03663136009346Hexanium® ACIFAC2-A012-S11L2025-02-20
03663136009353Hexanium® ACIFAC2-A012-S09L2025-02-20
03663136009360Hexanium® ACIFAC2-A012-S07L2025-02-20
03663136009384Hexanium® ACIFAC2-A012-L11C2025-02-20
03663136009391Hexanium® ACIFAC2-A012-L09C2025-02-20
03663136009407Hexanium® ACIFAC2-A012-L07C2025-02-20
03663136009414Hexanium® ACIFAC2-A012-L05C2025-02-20
03663136009421Hexanium® ACIFAC2-A012-M11C2025-02-20
03663136009438Hexanium® ACIFAC2-A012-M09C2025-02-20
03663136009445Hexanium® ACIFAC2-A012-M07C2025-02-20
03663136009452Hexanium® ACIFAC2-A012-M05C2025-02-20
03663136009469Hexanium® ACIFAC2-A012-S11C2025-02-20
03663136009476Hexanium® ACIFAC2-A012-S09C2025-02-20
03663136009483Hexanium® ACIFAC2-A012-S07C2025-02-20
03663136009490Hexanium® ACIFAC2-A012-S05C2025-02-20
03663136009261Hexanium® ACIFAC2-A012-L11L2025-02-19

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