TPS 5100-031-500

GUDID 07613327116441

TPS Micro Oscillating Saw Irr. Clip

STRYKER CORPORATION

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• Primary Device ID: 07613327116441
• NIH Device Record Key: 27ab651f-63dc-4238-8f05-1d3e2c4c21c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TPS
• Version Model Number: 5100031500
• Catalog Number: 5100-031-500
• 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	07613327116441 [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

[07613327116441]

Moist Heat or Steam Sterilization

[07613327116441]

Moist Heat or Steam Sterilization

[07613327116441]

Moist Heat or Steam Sterilization

[07613327116441]

Moist Heat or Steam Sterilization

[07613327116441]

Moist Heat or Steam Sterilization

[07613327116441]

Moist Heat or Steam Sterilization

[07613327116441]

Moist Heat or Steam Sterilization

[07613327116441]

Moist Heat or Steam Sterilization

[07613327116441]

Moist Heat or Steam Sterilization

[07613327116441]

Moist Heat or Steam Sterilization

[07613327116441]

Moist Heat or Steam Sterilization

[07613327116441]

Moist Heat or Steam Sterilization

[07613327116441]

Moist Heat or Steam Sterilization

[07613327116441]

Moist Heat or Steam Sterilization

[07613327116441]

Moist Heat or Steam Sterilization

[07613327116441]

Moist Heat or Steam Sterilization

[07613327116441]

Moist Heat or Steam Sterilization

[07613327116441]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-01-20
• Device Publish Date: 2016-09-23

On-Brand Devices [TPS]

• 07613327174892: Reusable Irrigation Cassette
• 07613327135619: Angled Medium "M" Irrigation Clip
• 07613327116557: TPS Universal Pla Ster Case Medium
• 07613327116540: TPS Universal Pla Ster Case Large
• 07613327116496: TPS Ent/Oral Max. Sterilization Case
• 07613327116489: System Sterilization Basket
• 07613327116472: Handpiece Sterilization Case
• 07613327116465: TPS Universal Pla Ster Case Small
• 07613327116441: TPS Micro Oscillating Saw Irr. Clip
• 07613327116434: TPS Micro Sag Saw Irr. Clip
• 07613327060607: Small-Joint Shaver Handpiece
• 07613327060591: TPS Footswitch , Two-Pedal
• 34546540991691: Connector Cleaner
• 04546540991676: Universal Drill Attachment Lubricant
• 04546540983930: XL Oscilliating Saw
• 04546540980816: Micro Driver
• 04546540977748: TPS Micro Oscillating Saw
• 04546540971272: Footswitch
• 04546540970275: Cord
• 04546540552747: Dura Guard Irrigation Tip
• 04546540401724: Unidirectional Footswitch
• 34546540075728: Disposable Irrigation Cassette, Dual Handpiece
• 34546540075711: Disposable Irrigation Cassette
• 04546540075703: Micro Reciprocating Saw Irrigation Clip
• 04546540074768: Straight Long "AM" Irrigation Clip
• 04546540074560: Dura Guard Irrigation Tip