EZ Access™

GUDID B5911425XL3

Wound Protector/ Retractor

V L V ASSOCIATES (INC)

Radial surgical retractor

• Primary Device ID: B5911425XL3
• NIH Device Record Key: af1bc92d-dd4d-494f-81ef-a98c440c9fc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ Access™
• Version Model Number: 1425-XL
• Company DUNS: 118877356
• Company Name: V L V ASSOCIATES (INC)
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B5911425XL0 [Primary]
HIBCC	B5911425XL3 [Package]; Contains: B5911425XL0; Package: Box [5 Units]; In Commercial Distribution

FDA Product Code

• KGW: Ring (Wound Protector), Drape Retention, Internal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-12-18

On-Brand Devices [EZ Access™]

• B5911425XS3: Wound Protector/ Retractor
• B5911425XL3: Wound Protector/ Retractor
• B5911425S3: Wound Protector/ Retractor
• B5911425M3: Wound Protector/ Retractor
• B5911425L3: Wound Protector/ Retractor