RetroFit Sterile Disposable Needle Guide 5315

GUDID 10841912101235

PROTEK MEDICAL PRODUCTS, INC.

Nonimplantable needle guide, single-use

• Primary Device ID: 10841912101235
• NIH Device Record Key: 90aafbf3-1914-4e58-a4f1-aae6519bf752
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RetroFit Sterile Disposable Needle Guide
• Version Model Number: 5315
• Catalog Number: 5315
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912101238 [Primary]
GS1	10841912101235 [Package]; Contains: 00841912101238; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973958

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• 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