TPS, Saber 5100121000S1

GUDID 07613153100379

Handswitch with Reversed Safety Switch

STRYKER CORPORATION

Surgical power tool hand-switch

• Primary Device ID: 07613153100379
• NIH Device Record Key: 51d089fe-b323-49e0-8eb2-04fa84a78d4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TPS, Saber
• Version Model Number: 5100121000S1
• Catalog Number: 5100121000S1
• Company DUNS: 196548481
• Company Name: STRYKER CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com
• Phone: +1(800)253-3210
• Email: Inst.Stryker.cs@Stryker.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613153100379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032117

FDA Product Code

• EIA: UNIT, OPERATIVE DENTAL

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[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 Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-20
• Device Publish Date: 2018-09-24

Devices Manufactured by STRYKER CORPORATION

• 37613327548205 - Neptune SafeAir: 2025-01-14 Telescopic Smoke Evacuation Pencil, Push Button, Coated, No PVC
• 07613327273120 - TRIO: 2025-01-03 PEDICULAR SCREWDRIVER SHAFT
• 07613327273144 - TRIO +: 2025-01-03 SELF HOLDING PEDICULAR SCREWDRIVER
• 07613327273175 - TRIO +: 2025-01-03 FLEXIBLE EXTENDER III
• 07613327273182 - TRIO: 2025-01-03 ROD BENDER
• 07613327273205 - TRIO: 2025-01-03 SPONDYLOSISTHESIS REDUCTION INSTRUMENT
• 07613327273212 - TRIO: 2025-01-03 SPONDYLOLISTHESIS REDUCTION INSTRUMENT
• 07613327273243 - TRIO +: 2025-01-03 FLEXIBLE EXTENDER II