ACCULIF 900301

GUDID 07613327067071

PL Tubing Set

Stryker Corporation

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 07613327067071
• NIH Device Record Key: c507e1bb-1123-4a63-95bf-94b5307e57bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCULIF
• Version Model Number: 900301
• Catalog Number: 900301
• Company DUNS: 149183167
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327067071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132505

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-16
• Device Publish Date: 2016-09-24

On-Brand Devices [ACCULIF]

• 07613327106046: PL INSERTION HANDLE INNER SHAFT
• 07613327106039: PL TRIAL
• 07613327106022: TL TRIAL
• 07613327106008: INSTRUMENT TRAY BASE
• 07613327105995: PL TRIAL
• 07613327105988: PL TRIAL
• 07613327105971: PL TRIAL
• 07613327105964: TL TRIAL
• 07613327105957: TL TRIAL
• 07613327105940: TL INSERTION HANDLE
• 07613327105933: PL TRIAL
• 07613327105926: PL INSERTION HANDLE
• 07613327105919: GRAFT INSERTION PUSHER
• 07613327105902: PL TRIAL
• 07613327105896: GRAFT INSERTION CANNULA
• 07613327105889: TL INSERTION HANDLE INNER SHAFT
• 07613327105872: SLAP HAMMER
• 07613327105865: INSERTION HANDLE END CAP
• 07613327105858: INSERTION HANDLE ROTATOR KNOB
• 07613327105841: TL TRIAL
• 07613327105834: TL TRIAL
• 07613327105827: TL TRIAL
• 07613327105810: PREP BLOCK
• 07613327105803: INSTRUMENT TRAY INSERT
• 07613327105797: INSTRUMENT TRAY LID
• 07613327068061: TL CAGE
• 07613327068054: TL CAGE
• 07613327068030: TL CAGE
• 07613327067118: SYRINGE BODY
• 07613327067101: SYRINGE PLUNGER
• 37613327067096: SYRINGE BODY O-RING (GREEN)
• 37613327067089: SYRINGE PLUNGER O-RING (RED)
• 07613327067071: PL Tubing Set
• 07613327067064: TL Tubing Set
• 07613327066777: PL CAGE
• 07613327066760: PL CAGE
• 07613327066753: PL CAGE