Sterilzation basket with lid

GUDID G006DJ4046SPEC927

Basket with lid for sterilization of adult endoscopes (External dimensions: 640 x 150 x 77 mm)

EFER ENDOSCOPY

Rigid optical bronchoscope

• Primary Device ID: G006DJ4046SPEC927
• NIH Device Record Key: 40c424cc-fa69-40da-bcfe-bbedf6b67605
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilzation basket with lid
• Version Model Number: DJ-4046-SPEC
• 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	G006DJ4046SPEC927 [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

Devices Manufactured by EFER ENDOSCOPY

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• 04250302227216 - Optical stent removal forceps: 2023-11-22 Optical stent removal forceps for BX-5500FA bronchial endoscope - 1 mobile jaw / head diameter 4 mm / working length 47 cm
• 04250302227223 - Optical biopsy forceps: 2023-11-22 Optical biopsy forceps for BX-5500FA bronchial endoscope - 2 mobile jaws / head diameter 4 mm / working length 47 cm
• G006DJ40431621 - Sterilization basket: 2023-11-22 Basket with lid for sterilization of pediatric endoscope (External dimensions: 460 x 80 x 52 mm)
• G006DJ4046SPEC927 - Sterilzation basket with lid: 2023-11-22Basket with lid for sterilization of adult endoscopes (External dimensions: 640 x 150 x 77 mm)
• G006DJ4046SPEC927 - Sterilzation basket with lid: 2023-11-22 Basket with lid for sterilization of adult endoscopes (External dimensions: 640 x 150 x 77 mm)
• G006DJ4371178 - Sterilization basket with lid: 2023-11-22 Basket for sterilization with lid and without silicone mat (External dimensions: 280 x 145 x 50 mm)
• G006DJ45611715 - Sterilization basket without lid: 2023-11-22 Basket for sterilization without lid and without silicone mat (External dimensions: 540 x 250 x 50 mm)