Sterile Disposable Endocavity Needle Guide Kit 5252

GUDID 10841912106070

Sterile Disposable Endocavity Needle Guide Kit for use with Alpinion E3-10, BK Medical 8819 & E10C4, Carestream E10C4 & E14C4, Hitachi Aloka Medical UST-679, Philips BP10-5ec (Affiniti 50, Affiniti 70, HD11, HD115 & HD7XE systems) & C9-4ec (HD7 XE w/3.0.1, software and above & HD9 systems) and Samsung Medison NEV4-9ES & NER4-9ES Ultrasound Transducers

PROTEK MEDICAL PRODUCTS, INC.

Body-orifice ultrasound imaging transducer cover, basic, sterile

• Primary Device ID: 10841912106070
• NIH Device Record Key: 4762c553-5268-433f-bfd6-5b9903e1c900
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Disposable Endocavity Needle Guide Kit
• Version Model Number: 5252
• Catalog Number: 5252
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912106073 [Primary]
GS1	10841912106070 [Package]; Contains: 00841912106073; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970891

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-07
• Device Publish Date: 2019-05-24

On-Brand Devices [Sterile Disposable Endocavity Needle Guide Kit]

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• 10841912105806: Sterile Disposable Endocavity Needle Guide Kit for use with Alpinion EC3-10 & EN-10, Philips C9-
• 10841912105608: Sterile Disposable Endocavity Needle Guide Kit for use with Hitachi C41V1 and EUP-73W Ultrasound
• 10841912105592: 5071
• 10841912105493: Sterile Disposable Endocavity Needle Guide Kit for use with Sonoscape 6V4 ultrasound transducer
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• 10841912105264: Sterile Disposable Endocavity Needle Guide Kit for use with: Chison D7C10L & V7-E, Esaote E8-5 R
• 10841912105219: Sterile Disposable Endocavity Needle Guide Kit for use with ATL C8-4v and Philips C8-4v, C9-3v &
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• 10841912105196: Sterile Disposable Endocavity Needle Guide Kit for use with ATL C8-4v and Philips C8-4v, C9-3v &
• 10841912105172: Sterile Disposable Endocavity Needle Guide Kit for use with Alpinion E3-10, BK Medical 8819 & E1
• 10841912105165: Sterile Disposable Endocavity Needle Guide Kit for use with Hitachi C41V1 and EUP-73W Ultrasound
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• 10841912105134: Sterile Disposable Endocavity Needle Guide Kit for Samsung Medison E3-12A Ultrasound Transducer
• 10841912105110: Sterile Disposable Endocavity Needle Guide Kit for Sonoscape EC9-5 Ultrasound Transducer
• 10841912105103: Sterile Disposable Endocavity Needle Guide for Sonoscape EC9-5 Ultrasound Transducer
• 10841912105097: Sterile Disposable Endocavity Needle Guide Kit for Sonoscape EC9-5 Ultrasound Transducer
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• 10841912104809: 5149
• 00841912104659: 5280
• 10841912104601: 5157
• 10841912104595: 5156
• 10841912104281: 5072
• 10841912101662: 5151
• 10841912101655: 5148
• 10841912101648: 5147
• 10841912101631: 5146
• 10841912101594: 5074
• 10841912106070: Sterile Disposable Endocavity Needle Guide Kit for use with Alpinion E3-10, BK Medical 8819 & E1
• 10841912106469: Sterile Disposable Endocavity Needle Guide Kit for use with Hitachi EUP-V33, EUP-V33W, EUP-V53W,
• 10841912106346: Sterile Disposable Endocavity Needle Guide Kit for use with Canon-Toshiba PVF-621VT, PVF-641VT,
• 10841912106162: Sterile Disposable Endocavity Needle Guide Kit for use with Hitachi C41V1 and EUP-73W Ultrasound
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