TPS, Saber 5100121000S1

GUDID 07613153100379

Handswitch with Reversed Safety Switch

STRYKER CORPORATION

Surgical power tool hand-switch
Primary Device ID07613153100379
NIH Device Record Key51d089fe-b323-49e0-8eb2-04fa84a78d4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTPS, Saber
Version Model Number5100121000S1
Catalog Number5100121000S1
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 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

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
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 Identifiers

Device Issuing AgencyDevice ID
GS107613153100379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIAUNIT, OPERATIVE DENTAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613153100379]

Ethylene Oxide


[07613153100379]

Ethylene Oxide


[07613153100379]

Ethylene Oxide


[07613153100379]

Ethylene Oxide


[07613153100379]

Ethylene Oxide


[07613153100379]

Ethylene Oxide


[07613153100379]

Ethylene Oxide


[07613153100379]

Ethylene Oxide


[07613153100379]

Ethylene Oxide


[07613153100379]

Ethylene Oxide


[07613153100379]

Ethylene Oxide


[07613153100379]

Ethylene Oxide


[07613153100379]

Ethylene Oxide


[07613153100379]

Ethylene Oxide


[07613153100379]

Ethylene Oxide


[07613153100379]

Ethylene Oxide


[07613153100379]

Ethylene Oxide


[07613153100379]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-20
Device Publish Date2018-09-24

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.