WASHER, BONE SCREW 405-688

GUDID 00846468041038

WASHER, BONE SCREW

Pioneer Surgical Technology, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00846468041038
• NIH Device Record Key: 4a00a511-4bd7-4f74-a71b-70a56d3e9c7a
• Commercial Distribution Discontinuation: 2016-07-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: WASHER, BONE SCREW
• Version Model Number: 405-688
• Catalog Number: 405-688
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468041038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102903

FDA Product Code

• OUR: Sacroiliac joint fixation

Sterilization

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

[00846468041038]

Moist Heat or Steam Sterilization

[00846468041038]

Moist Heat or Steam Sterilization

[00846468041038]

Moist Heat or Steam Sterilization

[00846468041038]

Moist Heat or Steam Sterilization

[00846468041038]

Moist Heat or Steam Sterilization

[00846468041038]

Moist Heat or Steam Sterilization

[00846468041038]

Moist Heat or Steam Sterilization

[00846468041038]

Moist Heat or Steam Sterilization

[00846468041038]

Moist Heat or Steam Sterilization

[00846468041038]

Moist Heat or Steam Sterilization

[00846468041038]

Moist Heat or Steam Sterilization

[00846468041038]

Moist Heat or Steam Sterilization

[00846468041038]

Moist Heat or Steam Sterilization

[00846468041038]

Moist Heat or Steam Sterilization

[00846468041038]

Moist Heat or Steam Sterilization

[00846468041038]

Moist Heat or Steam Sterilization

[00846468041038]

Moist Heat or Steam Sterilization

[00846468041038]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-12-10

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