Insulated Clik Tite 8001-064-037

GUDID 07613327175295

STRYKER CORPORATION

External cuff/pad connection tubing
Primary Device ID07613327175295
NIH Device Record Key4268a1f5-a9ed-4aa3-b5e6-dcb7044df1b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameInsulated Clik Tite
Version Model Number8001-064-037
Catalog Number8001-064-037
Company DUNS078470558
Company NameSTRYKER CORPORATION
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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327175295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWJSystem, thermal regulating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-21
Device Publish Date2016-12-16

Devices Manufactured by STRYKER CORPORATION

07613327262995 - XIA II2025-07-17 CORONAL BENDER LEFT
07613327263015 - XIA II2025-07-17 CORONAL BENDER RIGHT
07613327661989 - KNOTILUS+2025-06-24 2.9X15.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE
07613327661996 - KNOTILUS+2025-06-24 2.4X8.9MM KNOTILUS+ HIP ANCHOR - BIOCOMPOSITE
07613327662009 - KNOTILUS+2025-06-24 2.4X11.3MM KNOTILUS+ ANCHOR - BIOCOMPOSITE
07613327662016 - KNOTILUS+2025-06-24 2.9X12.5MM KNOTILUS+ HIP ANCHOR - BIOCOMPOSITE
07613327662023 - KNOTILUS+2025-06-24 2.9X12.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE
07613327662030 - ALPHAVENT2025-06-24 ALPHAVENT KNOTLESS SP, 4.75MM, BIOCOMPOSITE ANCHOR

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