Alatus ALA-45

GUDID 00851546007004

Alatus Vaginal Balloon Packing System Kit

RADIADYNE, L.L.C.

Vaginal speculum, single-use

• Primary Device ID: 00851546007004
• NIH Device Record Key: 4afb0d97-9885-4eb8-a113-734f27136882
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alatus
• Version Model Number: ALA-45 Unit Tray
• Catalog Number: ALA-45
• Company DUNS: 005744772
• Company Name: RADIADYNE, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 281-759-9600
• Email: leahroe@radiadyne.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851546007004 [Primary]
GS1	10851546007001 [Package]; Package: Shelf Box [5 Units]; In Commercial Distribution
GS1	20851546007008 [Package]; Contains: 10851546007001; Package: Shipper Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092534

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

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• 00851546007158 - QC MicroPSD: 2018-07-27 QC-calibrated microPSD sensor cable
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