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.

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00763000684112 - N/A2025-09-16 INSTRUMENT 9339095 CALIPER
00763000884833 - N/A2025-09-16 INSTRUMENT 7081912 DTS GUIDE
00763000885076 - N/A2025-09-16 DRILL BIT 7080613 NON STERILE 13MM
00763000885274 - N/A2025-09-16 TRAIL 8740041 10X14X11 CORNERSTONE SR
00763000885281 - N/A2025-09-16 TRAIL 8740141 11X14X11 CORNERSTONE SR
00763000885298 - N/A2025-09-16 TRAIL 8740241 12X14X11 CORNERSTONE SR

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