RetroFit Sterile Disposable Needle Guide

GUDID 00841912103355

PROTEK MEDICAL PRODUCTS, INC.

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 00841912103355
• NIH Device Record Key: 40a356d2-a267-4251-9389-45cc4d3daf3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RetroFit Sterile Disposable Needle Guide
• Version Model Number: 5300
• Company DUNS: 965417181
• Company Name: PROTEK MEDICAL PRODUCTS, 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: false
• 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	00841912103355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970893

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-16

On-Brand Devices [RetroFit Sterile Disposable Needle Guide]

• 00841912103355: 5300
• 10841912101327: 5325
• 10841912101310: 5323
• 10841912101303: 5322
• 10841912101297: 5321
• 10841912101280: 5320
• 10841912101273: 5319
• 10841912101266: 5318
• 10841912101259: 5317
• 10841912101242: 5316
• 10841912101235: 5315
• 10841912101228: 5314
• 10841912101211: 5313