FDA.reportPublic FDA data

Hallu®-FIX

Primary DI
10381780042099
Brand
Hallu®-FIX
Company
NEWDEAL
Model
129930ND
Device description
The stainless steel and radel container is used in the transport and the sterilization of the associated instruments and non sterile implants. It includes one base with reference 129931ND, one HALLU®-C plate rack with reference 129932ND, one HALLU®-S plate rack with reference 129933ND, one HALLU-FIX® screw rack with reference 129936ND and one lid with reference 996200ND.The transport and sterilization containers are not intended to maintain sterility.
Published
2017-05-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780042099PrimaryGS10
M248129930ND1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178004209910381780042099

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
536935331
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780045687K-WIRE115071ND115071ND2017-10-09
10381780045731K-WIRE115110ND115110ND2017-10-09
10381780045755K-WIRE115111ND115111ND2017-10-09
10381780045786K-WIRE115170ND115170ND2017-10-09
10381780045809K-WIRE115171ND115171ND2017-10-09
10381780045847K-WIRE115316ND115316ND2017-10-09
10381780045854K-WIRE115416ND115416ND2017-10-09
10381780041771QWIX®119932ND2017-05-26
10381780042136Hallu®-FIX129935ND2017-05-26
10381780042266ADVANSYS®169101ND2017-05-26
10381780042273ADVANSYS®169102ND2017-05-26
10381780042280ADVANSYS®169104ND2017-05-26
10381780042327ADVANSYS®188201ND2017-05-26
10381780042334ADVANSYS®188202ND2017-05-26
10381780042419IPP-ON®239000ND2017-05-26
10381780042426IPP-ON®239001ND2017-05-26
10381780042778PANTA®519920ND2017-05-26
10381780042822SURFIX®SET000ND2017-05-26
10381780042839SURFIX®SET100ND2017-05-26
10381780042846SURFIX®SET101ND2017-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376766133InvictusALPHATEC SPINE, INC.FSM2026-07-30
ESAM1380200003041STOMA®Storz am Mark GmbHFSM2026-07-30
ESAM1380210003041STOMA®Storz am Mark GmbHFSM2026-07-30
ESAM1387030003041STOMA®Storz am Mark GmbHFSM2026-07-30
03700569678968Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-28
10889950157623Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-07-28
00190376768748Segmental Plating SystemALPHATEC SPINE, INC.FSM2026-07-27
00810017915118Saber-C Instrument CaseELEVATION SPINE, INC.FSM2026-07-27
03700569674304Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674311Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674373Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674380Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674397Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674403Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674410Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674427Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674441Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674458Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569674465Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569680145Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569680152Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569680169Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
03700569680176Newclip InstrumentsNEWCLIP TECHNICSFSM2026-07-27
00190776422011MillenniumAvalign Technologies, Inc.FSM2026-07-24
00840536823717VerteGlide Spinal Growth Guidance SystemORTHOPEDIATRICS CORP.FSM2026-07-24
00840536823724VerteGlide Spinal Growth Guidance SystemORTHOPEDIATRICS CORP.FSM2026-07-24
07640221370846SCALASpineArt SAFSM2026-07-24
07640221370853SCALASpineArt SAFSM2026-07-24
07640221370860SCALASpineArt SAFSM2026-07-24
00190776421991MillenniumAvalign Technologies, Inc.FSM2026-07-23