Domia Front DOF201

GUDID B937DOF2011

Dormia 2Fr 11mm Stone Extractor

EPflex Feinwerktechnik GmbH.

Urinary stone retrieval basket, single-use

• Primary Device ID: B937DOF2011
• NIH Device Record Key: 54508842-7ed8-4797-b1b1-4c0da06bee88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Domia Front
• Version Model Number: DOF201
• Catalog Number: DOF201
• Company DUNS: 312527765
• Company Name: EPflex Feinwerktechnik GmbH.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B937DOF2010 [Primary]
HIBCC	B937DOF2011 [Package]; Contains: B937DOF2010; Package: Carton box [1 Units]; In Commercial Distribution

FDA Product Code

• FFL: Dislodger, Stone, Basket, Ureteral, Metal

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: 2021-08-02
• Device Publish Date: 2021-07-23

On-Brand Devices [Domia Front]

• B937DOF2081: Dormia 2Fr 8mm Stone Extractor
• B937DOF2011: Dormia 2Fr 11mm Stone Extractor
• B937DOF1581: Dormia 1.5Fr.8mm Stone Extractor
• B937DOF1511: Dormia 1.5Fr 11mm Stone Extractor