MakoMed MM2001

GUDID 16975424191324

Probe Cover , VIP film , Gel and Elastic Bands 13x122cm

EXACT MEDICAL MANUFACTURING, INC.

Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover Body-surface ultrasound imaging transducer cover

• Primary Device ID: 16975424191324
• NIH Device Record Key: 7c9310a3-4a7d-4330-a19b-4fdd87c77dcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MakoMed
• Version Model Number: MM2001
• Catalog Number: MM2001
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975424191327 [Primary]
GS1	16975424191324 [Package]; Contains: 06975424191327; Package: Case [20 Units]; In Commercial Distribution
GS1	26975424191321 [Package]; Package: Case [3 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: 2023-04-12
• Device Publish Date: 2023-04-04

On-Brand Devices [MakoMed]

• 16975424191355: Band Bag with tape 127x91cm- 50"x36"
• 16975424191348: Band Bag with Tape and Elastic Bands 91x91cm
• 16975424191331: Band Bag with Tape and Elastic Bands 91x56 cm - 36" x 22"
• 16975424191324: Probe Cover , VIP film , Gel and Elastic Bands 13x122cm
• 16975424191317: Probe Cover , VIP film , Gel and Elastic Bands 13x61cm
• 16975424191300: Microscope Drape - Zeiss MD 117x203cm
• 16975424191294: Microscope Drape - Leica 137 x 381 cm
• 16975424191287: Microscope Drape- Zeiss MD, 137x381cm - 54"x150"