Zimmer Cannulated Screw System 00-1147-014-31

GUDID 00846468067595

Screw

Pioneer Surgical Technology, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00846468067595
• NIH Device Record Key: a4485f9f-a3a2-4ac8-b1bf-24b46f3b039f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zimmer Cannulated Screw System
• Version Model Number: 00-1147-014-31
• Catalog Number: 00-1147-014-31
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• 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: 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(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468067595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003496

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

[00846468067595]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-05
• Device Publish Date: 2020-09-25

On-Brand Devices [Zimmer Cannulated Screw System]

• 00846468074739: LONG LENGTH BIT NOSE ATTACHMENT
• 00846468074722: STANDARD BIT NOSE ATTACHMENT
• 00846468074715: TENSIONER BIT LEVER ARM ATTACHMENT
• 00846468074708: LONG TENSIONER BIT
• 00846468074692: STANDARD TENSIONER BIT
• 00846468074685: CABLE TENSIONER
• 00846468074678: DEPTH GAUGE, 3.2mm X 300mm GUIDE WIRE
• 00846468074661: GUIDE PIN, 3.2mm X 295 mm SMOOTH SHAFT DRILL POINT
• 00846468074654: GUIDE PIN, 3.2mm X 295mm SMOOTH SHAFT TROC TIP
• 00846468074647: GUIDE PIN, 3.2mm X 295 mm PART THREAD TROCAR TIP
• 00846468074630: GUIDE PIN, 1.6mm X 150mm SMOOTH SHAFT TROC TIP
• 00846468074623: GUIDE PIN, 3.2mm X 225 mm SMOOTH SHAFT DRILL POINT
• 00846468074616: GUIDE PIN, 3.2mm X 225mm SMOOTH SHAFT TROC TIP
• 00846468074609: GUIDE PIN, 2.4mm X 224mm SMOOTH SHAFT TROC TIP
• 00846468074593: GUIDE PIN, 1.6mm X 226mm SMOOTH SHAFT TROC TIP
• 00846468074586: GUIDE PIN, 1.25mm X 150mm SMOOTH SHAFT TROC TIP
• 00846468074579: GUIDE PIN, 3.2mm X 225 mm PART THREAD TROCAR TIP
• 00846468074562: GUIDE PIN, 2.4mm X 224mm PART THREAD TROCAR TIP
• 00846468074555: GUIDE PIN, 1.6mm X 226 mm PART THREAD TROC TIP
• 00846468074548: GUIDE PIN, 1.25mm X 150mm PART THREAD TROCAR TIP
• 00846468074531: GUIDE PIN, 1.6mm X 150mm PART THREAD TROCAR TIP
• 00846468074524: T-HANDLE EZ OUT (4.5mm, 5.5mm, 6.5mm, 7.0mm, 7.5mm SCREWS)
• 00846468074517: T-HANDLE EZ OUT (3.0mm, 3.5mm, 4.0mm SCREWS)
• 00846468074500: SCREW HOLDING SLEEVE, 6.5mm/7.0mm/7.5mm
• 00846468074494: SCREW HOLDING SLEEVE, 4.5mm/5.5mm
• 00846468074487: SCREW HOLDING SLEEVE, 3.0mm
• 00846468074470: SCREW HOLDING SLEEVE, 3.5mm/4.0mm
• 00846468074463: SCREW FORCEPS
• 00846468074456: CLEANING BRUSH, 3.2mm
• 00846468074449: 7.5MM CANNULATED SCREW CASE BASE
• 00846468074432: CLEANING BRUSH, 2.4mm
• 00846468074425: 7.0MM CANNULATED SCREW TRAY
• 00846468074418: CLEANING BRUSH, 1.6mm
• 00846468074401: STERILIZATION CASE, 7.5mm
• 00846468074395: CLEANING BRUSH, 1.25mm
• 00846468074388: STYLET, 3.2mm
• 00846468074371: STYLET, 2.4mm
• 00846468074364: STYLET, 1.6mm
• 00846468074357: Sterilization Case, Top Tray, 7.0 mm
• 00846468074340: STERILIZATION CASE, 7.0mm
• 00846468074333: STYLET, 1.25mm
• 00846468074326: TROCAR, 3.2mm
• 00846468074319: TROCAR, 2.4mm
• 00846468074302: TROCAR, 1.6mm
• 00846468074296: STERILIZATION CASE, 6.5mm
• 00846468074289: TROCAR, 1.25mm
• 00846468074272: CANNULATED HEXAGONAL DRIVER, 2.5mm
• 00846468074265: PARALLEL PIN GUIDE, 3.2mm
• 00846468074258: ADJUSTABLE PARALLEL PIN GUIDE, 3.2mm
• 00846468074241: ADJUSTABLE PARALLEL PIN GUIDE, 2.4mm