TRAcelet™

GUDID 20643169900909

COMPRESSION DEVICE TRACR TRACELET 5PK GL

MEDTRONIC, INC.

Radial artery compression device
Primary Device ID20643169900909
NIH Device Record Key60da22f8-b166-41f4-be04-f18735312827
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRAcelet™
Version Model NumberTRACR
Company DUNS006261481
Company NameMEDTRONIC, 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 Perscriptionfalse
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

Device Dimensions

Length19.2 Centimeter
Length19.2 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, direct sunlight, extreme temperatures, or high humidity during storage.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid exposure to water, direct sunlight, extreme temperatures, or high humidity during storage.

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169900905 [Primary]
GS120643169900909 [Package]
Contains: 00643169900905
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXCCLAMP, VASCULAR

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 Date2017-01-15

On-Brand Devices [TRAcelet™]

20643169900909COMPRESSION DEVICE TRACR TRACELET 5PK GL
20643169900893COMPRESSION DEVICE TRACL TRACELET 5PK GL

Trademark Results [TRAcelet]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRACELET
TRACELET
90257814 not registered Live/Pending
Royal Caribbean Cruises Ltd.
2020-10-15
TRACELET
TRACELET
86213360 5324064 Live/Registered
Medtronic Vascular, Inc.
2014-03-06
TRACELET
TRACELET
78599920 not registered Dead/Abandoned
Ramsey, David S.
2005-04-01
TRACELET
TRACELET
77820772 3905290 Dead/Cancelled
Silverco Inc.
2009-09-04
TRACELET
TRACELET
75276127 not registered Dead/Abandoned
ADSHEL INC.
1997-04-17

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