DP400CE

GUDID 57613327169329

STRYKER CORPORATION

General-purpose patient temperature probe, single-use
Primary Device ID57613327169329
NIH Device Record Keyf6cc82b5-1249-4977-ac7b-2f1d4bc74358
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDP400CE
Catalog NumberDP400CE
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327169324 [Primary]
GS157613327169329 [Package]
Contains: 07613327169324
Package: case [10 Units]
In Commercial Distribution

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by STRYKER CORPORATION

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
07613327662047 - ALPHAVENT2025-06-24 ALPHAVENT KNOTLESS SP, 5.5MM, BIOCOMPOSITE ANCHOR
07613327662054 - ALPHAVENT2025-06-24 ALPHAVENT KNOTLESS SP, 6.5MM, BIOCOMPOSITE ANCHOR

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