Pivot Guardian 3105-000-950

GUDID 07613327380378

PostFree Perineal Accessory Kit

STRYKER CORPORATION

Surgical counter-traction post

• Primary Device ID: 07613327380378
• NIH Device Record Key: 3abfe3f3-b2a0-4b33-87e3-95ed4fc3fc28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pivot Guardian
• Version Model Number: 3105000950
• Catalog Number: 3105-000-950
• Company DUNS: 187502109
• Company Name: STRYKER CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• 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(866)624-4422
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327380378 [Primary]

FDA Product Code

• HST: Apparatus, traction, non-powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-23
• Device Publish Date: 2017-10-19

On-Brand Devices [Pivot Guardian]

• 07613327419689: 3105000201
• 37613327419048: Pivot Guardian Disposable Kit, Medium
• 37613327419031: Pivot Guardian Disposable Kit, Large
• 37613327419024: Pivot Guardian Disposable Kit, Small
• 07613327380385: PostFree Tabletop Extension, US
• 07613327380378: PostFree Perineal Accessory Kit
• 07613327380361: PostFree Frame
• 37613327376402: PostFree Patient Safety Kit, Large
• 37613327376396: PostFree Patient Safety Kit, Medium
• 37613327376389: PostFree Patient Safety Kit, Small
• 07613327575484: 3105000303
• 07613327574838: 3105000304
• 07613327565812: 3105000300
• 07613327565782: 3105000313
• 07613327565775: 3105000301
• 07613327565379: 3105000306
• 07613327563818: 3105000308
• 37613327570480: Pivot Guardian Direct Disposable Kit Medium
• 37613327570473: Pivot Guardian Direct Disposable Kit Large
• 37613327570466: Pivot Guardian Direct Disposable Kit Small
• 07613327581539: 3105000305