Bella Blankets

GUDID 00815137020247

Protective Coverlets for Mammography - 29.2cm x 33.0cm

Beekley Corporation

Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use

• Primary Device ID: 00815137020247
• NIH Device Record Key: 81e18f41-4d81-4d04-9d08-e6494d49d4f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bella Blankets
• Version Model Number: 311
• Company DUNS: 001157841
• Company Name: Beekley Corporation
• Device Count: 50
• 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: 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
GS1	00815137020247 [Primary]
GS1	10815137020244 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073262

FDA Product Code

• IZH: System, X-Ray, Mammographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-01

On-Brand Devices [Bella Blankets]

• 00815137021251: Protective Coverlets for Mammography - 29.2cm x 33.0cm
• 00815137021244: Protective Coverlets for Mammography - 22.9cm x 27.9cm
• 00815137020247: Protective Coverlets for Mammography - 29.2cm x 33.0cm
• 00815137020230: Protective Coverlets for Mammography - 22.9cm x 27.9cm