SAVI® SAVI-06MINIGAMMA/B

GUDID 00884450434338

MERIT MEDICAL SYSTEMS, INC.

General-purpose brachytherapy system applicator, manual

• Primary Device ID: 00884450434338
• NIH Device Record Key: 2b0fcb4e-7f5f-49cc-bff6-13ef2826ae39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAVI®
• Version Model Number: 00884450434338
• Catalog Number: SAVI-06MINIGAMMA/B
• Company DUNS: 117056277
• Company Name: MERIT MEDICAL SYSTEMS, 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: true
• 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: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450434338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081677

FDA Product Code

• JAQ: System, applicator, radionuclide, remote-controlled

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: 2020-04-24
• Device Publish Date: 2020-04-16

On-Brand Devices [SAVI®]

• 10884450434274: 00884450434277
• 10884450433949: 00884450433942
• 00884450434994: 00884450434994
• 00884450434413: 00884450434413
• 00884450434383: 00884450434383
• 00884450434291: 00884450434291
• 00884450433928: 00884450433928
• 00884450433904: 00884450433904
• 00884450434338: 00884450434338
• 10884450434236: 00884450434239
• 00884450434437: 00884450434437
• 00852205006444: 00852205006444
• 00852205006345: 00852205006345