Silicone mat

GUDID G006DJ4928195

Silicone mat (Dimensions: 500 x 300 mm)

EFER ENDOSCOPY

Rigid optical bronchoscope

• Primary Device ID: G006DJ4928195
• NIH Device Record Key: 651dc5d3-7e41-4aef-a4a0-42176c25df13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone mat
• Version Model Number: DJ-4928
• Company DUNS: 286097451
• Company Name: EFER ENDOSCOPY
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G006DJ4928195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854414

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-22
• Device Publish Date: 2023-11-14

On-Brand Devices [Silicone mat]

• G006DJ4929197: Silicone mat (Dimensions: 480 x 250 mm)
• G006DJ4928195: Silicone mat (Dimensions: 500 x 300 mm)