HEALIX KNOTLESS BR 222286

GUDID 10886705020386

HEALIX Knotless BR Anchor TCP/PLGA Absorbable Anchor 4.75mm

DEPUY MITEK, LLC

Tendon/ligament bone anchor, bioabsorbable
Primary Device ID10886705020386
NIH Device Record Key3d9190a0-1fe8-4462-a88b-71d1a3642488
Commercial Distribution Discontinuation2021-01-28
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEALIX KNOTLESS BR
Version Model Number222286
Catalog Number222286
Company DUNS190572854
Company NameDEPUY MITEK, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110886705020386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2021-01-07
Device Publish Date2015-09-01

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20886705011091 - NA2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 10.5mm
20886705011107 - NA2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 11.5mm
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