BIRD EMD0003

GUDID 00860011750215

Breast Implant Removal Device, 2 Pack

Gaylord Solutions LLC

General-purpose surgical suction system, vacuum

• Primary Device ID: 00860011750215
• NIH Device Record Key: 936080e1-942f-4bfb-8a38-30c9ec0eb883
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIRD
• Version Model Number: EMD0003
• Catalog Number: EMD0003
• Company DUNS: 119212577
• Company Name: Gaylord Solutions LLC
• Device Count: 2
• 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	00860011750215 [Primary]
GS1	00860011750222 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN220082

FDA Product Code

• QVS: Breast Implant Suction Retrieval Device

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: 2024-04-08
• Device Publish Date: 2024-03-29