5407-300-100

GUDID 07613327177367

Extender

STRYKER CORPORATION

Drilling power tool attachment, basic
Primary Device ID07613327177367
NIH Device Record Keyf888dfed-1160-4bf6-8c1e-27665292f6a1
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5407-300-100
Catalog Number5407-300-100
Company DUNS196548481
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 Batchfalse
Serial Numbertrue
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)253-3210
EmailInst.Stryker.cs@Stryker.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327177367 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327177367]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-01-20
Device Publish Date2016-09-23

Devices Manufactured by STRYKER CORPORATION

07613327634914 - Neptune2024-04-24 SMART DOCKING STATION (120V)
07613327627664 - KNOTILUS+2024-03-15 2.9X12.5MM KNOTILUS+ HIP ANCHOR - PEEK
07613327627701 - KNOTILUS+2024-03-15 2.4X8.9MM KNOTILUS+ HIP ANCHOR - PEEK
07613327623796 - KNOTILUS+2024-03-13 2.4X8.9MM DRILL, HIP
07613327623833 - KNOTILUS+2024-03-13 2.4X8.9MM DRILL, HARD BONE, HIP
07613327634686 - Iconix2024-03-12 Iconix DC Guide for 1.4mm anchor
07613327634693 - Iconix2024-03-12
07613327616675 - SPY2024-03-06

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