PS Medical EDM Quick-Attach Pole Clamp

GUDID 00763000281212

CLMP 46137 QUICK ATTACH POLE W/LAS

MEDTRONIC PS MEDICAL, INC.

Laser patient positioning system
Primary Device ID00763000281212
NIH Device Record Key0d85cd21-1457-4b50-a635-9c2108708419
Commercial Distribution StatusIn Commercial Distribution
Brand NamePS Medical EDM Quick-Attach Pole Clamp
Version Model Number46137
Company DUNS089055867
Company NameMEDTRONIC PS MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
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 Identifiers

Device Issuing AgencyDevice ID
GS100763000281212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWMDevice, monitoring, intracranial pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-08
Device Publish Date2023-04-30

Devices Manufactured by MEDTRONIC PS MEDICAL, INC.

00763000950941 - Duet EDMS2025-03-31 EDMS 46913 DUET INTERLINK SITES/US
00763000950972 - Duet EDMS2025-03-31 EDMS 46914 DUET BLUECORE SITES/US
00763000281243 - Exacta Pole Clamp with laser level2025-02-25 CLAMP 46715 EXACTA PL NEG 25CM W/LSR
00763000281229 - Exacta Pole Clamp with laser level2025-02-24 ASSY 46711 EXACTA POLE CLAMP W/LASER
00763000413255 - Exacta™2025-02-10 ASSY 46711 EXACTA POLE CLAMP W/LASER
00763000413262 - Exacta™2025-02-10 CLAMP 46715 EXACTA PL NEG 25CM W/LSR
00763000422653 - Valve, StrataMR II, Regular2025-01-31 ASSY 46965MR SHUNT STRATAMR II REG CE
00763000422677 - Snap Shunt Assembly, StrataMR II, Regular2025-01-31 SHUNT 46966MR SNP ASSY STRATAMRII REG CE

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.