BIOMET

GUDID 00815634020283

RIGID ENDOSCOPIC AEROSOL APP. 5MM DIA X 40CM (16 IN) 1:1

MICROMEDICS, INC.

Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel Open-surgery adhesive/sealant applicator, dual-channel

• Primary Device ID: 00815634020283
• NIH Device Record Key: 1e2e8c16-bb9b-47c0-9873-a24dddfdb8c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOMET
• Version Model Number: 800-0217
• Company DUNS: 066839630
• Company Name: MICROMEDICS, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815634020283 [Primary]
GS1	10815634020280 [Package]; Package: SHELF BOX [1 Units]; In Commercial Distribution
GS1	20815634020287 [Package]; Contains: 10815634020280; Package: SHIP BOX [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042834

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-25

On-Brand Devices [BIOMET]

• 00815634020283: RIGID ENDOSCOPIC AEROSOL APP. 5MM DIA X 40CM (16 IN) 1:1
• 00815634020276: RIGID ENDOSCOPIC TIP 1:1 RATIO 5 MM X 40 CM
• 00815634020269: APPLICATOR SPRAY TIP DUAL CANNULA, MALLEABLE 5MM X 32CM (12.5IN)