INVISx®

GUDID 20643169466306

LOCKS 60100 INVISX 2PK CE

MEDTRONIC PS MEDICAL, INC.

Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clamp Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip Cranial bone flap fixation clip
Primary Device ID20643169466306
NIH Device Record Keyc4e5d2bd-63fa-4a95-98a9-9ba031989b72
Commercial Distribution StatusIn Commercial Distribution
Brand NameINVISx®
Version Model Number60100
Company DUNS089055867
Company NameMEDTRONIC PS MEDICAL, 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
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

Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter
Width2.54 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169466302 [Primary]
GS120643169466306 [Package]
Contains: 00643169466302
Package: PK [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXNPLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

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 Date2015-07-16

On-Brand Devices [INVISx®]

00643169103467INSTR 60710 INVISX TENSIONING REUSE
00643169498242SET 60700 INVISX CRNL FXTION INSTR
00643169498006INSTR 60710 INVISX TENSIONING REUSE
00643169497771TRAY 60730 INVISX INSTRUMENT
20643169466306LOCKS 60100 INVISX 2PK CE
00681490881579TRAY 60730 INVISX INSTRUMENT
00681490881555INSTRUMENT 60720 INVISX TRIMMING REU
00681490881470SET 60700 INVISX CRNL FXTION INSTR

Trademark Results [INVISx]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INVISX
INVISX
78043473 2660838 Live/Registered
Medtronic, Inc.
2001-01-17

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