SYRINGE ATR INFLATION HP

GUDID 00763000557065

SYRINGE A08E-ATR INFLATION HP

MEDTRONIC SOFAMOR DANEK, INC.

Catheter/overtube balloon inflator, single-use
Primary Device ID00763000557065
NIH Device Record Key87ea10e3-43de-40f6-a647-86bbac16a2c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSYRINGE ATR INFLATION HP
Version Model NumberA08E-ATR
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000557065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXTInjector and syringe, angiographic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-12
Device Publish Date2023-06-03

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00643169652798 - CD HORIZON® SOLERA® Spinal System2024-07-16 ROD X0914082 DUAL BEND 5.5 CCM PLS L 400
00643169652804 - CD HORIZON® SOLERA Spinal System2024-07-16 ROD X0914083 DUAL BEND 5.5 CCM PLS X 490
00763000658687 - MSB Reusable Instruments2024-07-16 HOLDER EX0322005 PLATE
00763000825829 - CD Horizon™ ModuLeX™ Spinal System2024-07-16 DRIVER SHAFT 5596077 CANN RATCHET LOCK
00763000825836 - CD Horizon™ ModuLeX™ Spinal System2024-07-16 SHANK DRIVER 5596078 CANN RATCHET LOCK
00763000825843 - CD Horizon™ ModuLeX™ Spinal System2024-07-16 SHNK DRVR 5596079 CAN RTCH LCK DPTH STOP
00763000825850 - CD Horizon™ ModuLeX™ Spinal System2024-07-16 SHANK DRIVER 5597413 RATCHET LOCK
00763000825898 - CD Horizon™ ModuLeX™ Spinal System2024-07-16 DRIVER SHAFT NAV5596077 CANN RATCHT LOCK

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