0212-010-000

GUDID 34546540184789

3/4 Perforation Flat Silicone Wound Drain

STRYKER CORPORATION

Whole-blood-recovery autotransfusion system, powered Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable
Primary Device ID34546540184789
NIH Device Record Key4ca622ec-7822-4b51-bfd1-3af8e4886fab
Commercial Distribution Discontinuation2019-04-01
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number0212010000
Catalog Number0212-010-000
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
Phone+1(800)253-3210
EmailInst.Stryker.cs@Stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@Stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@Stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@Stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@Stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@Stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@Stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@Stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@Stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@Stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@Stryker.com

Device Dimensions

Width7 Millimeter
Width7 Millimeter
Width7 Millimeter
Width7 Millimeter
Width7 Millimeter
Width7 Millimeter
Width7 Millimeter
Width7 Millimeter
Width7 Millimeter
Width7 Millimeter
Width7 Millimeter
Width7 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104546540184788 [Primary]
GS134546540184789 [Package]
Contains: 04546540184788
Package: pack [10 Units]
Discontinued: 2019-04-01
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CACAPPARATUS, AUTOTRANSFUSION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-19
Device Publish Date2015-09-24

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.