TYRX™ Neuro Absorbable Antibacterial Envelope - Large

GUDID 00643169624795

ENVELOPE NMRM6133 NEURO ABSORB LRG US

MEDTRONIC, INC.

Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable Implantable pulse generator mesh bag, bioabsorbable
Primary Device ID00643169624795
NIH Device Record Key3d815f91-995d-4002-ab64-e4049f33c5bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameTYRX™ Neuro Absorbable Antibacterial Envelope - Large
Version Model NumberNMRM6133
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169624795 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTLMesh, surgical, polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-06-10

Devices Manufactured by MEDTRONIC, INC.

20763000825212 - NA2024-03-25 CUSTOM PACK SS12B17R1 5PK CHANGEOUT
00763000825324 - NA2024-03-25 78.800
00763000940300 - NA2024-03-25 CUSTOM PACK BB6H26R45 ADULT CK
00763000941055 - NA2024-03-25 CUSTOM PACK HY9M47R20 ADLT MAIN
20763000941073 - NA2024-03-25 CUSTOM PACK BB12G07R 5PK ACC LINE
00763000941086 - NA2024-03-25 CUSTOM PACK BB12F62R2 UOFU HEART PA
00763000941093 - NA2024-03-25 CUSTOM PACK HY8B05R11 HBC
00763000941352 - NA2024-03-25 CUSTOM PACK BB12F31R E TRANS

Trademark Results [TYRX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TYRX
TYRX
86213023 4736448 Live/Registered
MEDTRONIC, INC.
2014-03-06
TYRX
TYRX
76571469 3022471 Live/Registered
MEDTRONIC, INC.
2004-01-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.