Sterile Disposable Endocavity Needle Guide 5455

GUDID 10841912107107

Sterile Disposable Endocavity Needle Guide for Ultrasound Transducers

PROTEK MEDICAL PRODUCTS, INC.

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• Primary Device ID: 10841912107107
• NIH Device Record Key: 43daa0f5-2304-48d7-9b0f-98b3bb463391
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Disposable Endocavity Needle Guide
• Version Model Number: 5455
• Catalog Number: 5455
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912107100 [Primary]
GS1	10841912107107 [Package]; Contains: 00841912107100; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971115

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-11
• Device Publish Date: 2022-04-01

On-Brand Devices [Sterile Disposable Endocavity Needle Guide]

• 10841912105912: Sterile Disposable Endocavity Needle Guide for use with Samsung EV2-10A Ultrasound Transducers
• 10841912105905: Sterile Disposable Endocavity Needle Guide for use with GE IC9-RS Ultrasound Transducers
• 10841912105899: Sterile Disposable Endocavity Needle Guide for use with Sonoscape EC2 Ultrasound Transducers
• 10841912105776: Sterile Disposable Endocavity Needle Guide for use with Chison D7C10L, V7-E
• 10841912105769: Sterile Disposable Endocavity Needle Guide for use with Chison D6C12L, V6-A Ultrasound Transduce
• 10841912105752: Sterile Disposable Endocavity Needle Guide for use with Sonosite ICT, ICTe, ICTx and ICTxp Ultra
• 10841912105745: Sterile Disposable Endocavity Needle Guide for use with Siemens EC9-4 (Acuson NX2™, NX3™, NX
• 10841912105738: Sterile Disposable Endocavity Needle Guide for use with Philips C9-4v Ultrasound Transducers (SP
• 10841912105721: Sterile Disposable Endocavity Needle Guide for use with Samsung EA2-11B Ultrasound Transducers
• 10841912105462: 5285
• 10841912105288: Sterile Disposable Endocavity Needle Guide for use with Toshiba PVT-781VT, PVU-781VT & 11C3 Ultr
• 10841912105189: Sterile Disposable Endocavity Needle Guide for use with ATL C8-4v and Philips C8-4v, C9-3v & C10
• 10841912105127: Sterile Disposable Endocavity Needle Guide for Samsung Medison E3-12A Ultrasound Transducer
• 10841912105080: Sterile Disposable Endocavity Needle Guide for Sonoscape EC9-5 Ultrasound Transducer
• 10841912104878: 5370
• 10841912104670: 5550
• 10841912104342: 5154
• 10841912104298: 5250
• 10841912103857: 5142
• 10841912101839: 9003
• 10841912101822: 9002
• 10841912101815: 9001
• 10841912101785: 5532
• 10841912101761: 5531
• 10841912101754: 5383
• 10841912101747: 5382
• 10841912101730: 5381
• 10841912101716: 5380
• 10841912101709: 5178
• 10841912101693: 5174
• 10841912101624: 5145
• 10841912101600: 5144
• 10841912101587: 5070
• 10841912106018: Sterile Disposable Endocavity Needle Guide for use with Samsung EA2-11AR & EA2-11AV Ultrasound T
• 10841912106025: Sterile Disposable Endocavity Needle Guide for use with Samsung EA2-11AR & EA2-11AV Ultrasound T
• 10841912106124: 5281
• 10841912106384: Sterile Disposable Endocavity Needle Guide for use with Sonoscape 6V3 (2016 Model & Newer)
• 10841912106308: Sterile Disposable Endocavity Needle Guide for use with Philips -ATL C9-5, C9-5ec & C9-5ICT Ultr
• 10841912106612: Sterile Disposable Endocavity Needle Guide for use with Esaote EC123, EC1123, SE3123, SE3133, TR
• 10841912106605: Sterile Disposable Endocavity Needle Guide for use with Samsung Medison EC4-9, EC4-9/10ED, EC4-9
• 10841912106759: Sterile Disposable Endocavity Needle Guide for use with Samsung Medison 3D5-8EK & 3D5-9EK Ultras
• 10841912107107: Sterile Disposable Endocavity Needle Guide for Ultrasound Transducers