DYNAMIC COMPRESSION SMA Staple System

GUDID 00721902662645

STAPLE 8162104 4MM X 10MM 2PRONG SMA

MEDTRONIC SOFAMOR DANEK, INC.

Bone staple Bone staple Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable
Primary Device ID00721902662645
NIH Device Record Keye1a09d03-a3ee-41d5-975c-4ab6cf995986
Commercial Distribution StatusIn Commercial Distribution
Brand NameDYNAMIC COMPRESSION SMA Staple System
Version Model Number8162104
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, 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 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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100721902662645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDRSTAPLE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


[00721902662645]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-07-31

On-Brand Devices [DYNAMIC COMPRESSION SMA Staple System]

00721902831744STAPLE 8164614 14MMX15MM 4PRNG SMA
00721902831737STAPLE 8164612 12MMX14MM 4PRNG SMA
00721902831713STAPLE 8164610 10MM X 13MM 4 PRONG SMA
00721902831706STAPLE 8164608 8MM X 12MM 4 PRONG SMA
00721902831690STAPLE 8164606 6MM X 11MM 4 PRONG SMA
00721902831683STAPLE 8164604 4MM X 10MM 4 PRONG SMA
00721902671838STAPLE 8162110 10MM X 13MM 2PRONG SMA
00721902671814STAPLE 8162108 8MM X 12MM 2PRONG SMA
00721902671784STAPLE 8162106 6MM X 11MM 2PRONG SMA
00721902662645STAPLE 8162104 4MM X 10MM 2PRONG SMA
008850744238905MM X 10MM SMA 4-PRONG STAPLE
00885074051444STAPLE 8162103 3MM X 9MM TWO PRONG SMA
00885074051437STAPLE 8162102 2MM X 9MM TWO PRONG SMA

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