Defries Industries DEF648

GUDID 00850033380927

Drawstring Probe Cover 23cm x 1m

EXACT MEDICAL MANUFACTURING, INC.

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 00850033380927
• NIH Device Record Key: 72eb9739-cac3-4b30-ad1d-5432eb8e8f24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Defries Industries
• Version Model Number: DEF648
• Catalog Number: DEF648
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850033380910 [Primary]
GS1	00850033380927 [Package]; Contains: 00850033380910; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211969

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2021-12-17
• Device Publish Date: 2021-12-09

On-Brand Devices [Defries Industries]

• 00850033380989: Ultrasound Probe Cover 26cm x 1.5m (Sealed End) with Elastic Bands
• 00850033380965: Ultrasound Probe Cover Sealed End 23cm x 80cm
• 00850033380941: Drawstring Probe Cover 23cm x 1.5m
• 00850033380927: Drawstring Probe Cover 23cm x 1m
• 00850033380897: Ultrasound Probe Cover 23cm x 1.5m