MOLLI

GUDID 00850024195035

MOLLI Introducer & MOLLI Marker (8 cm, 14GA) For use with the MOLLI System Note, the Introducer is MR Unsafe, however, the implantable Marker is MR Conditional.

Molli Surgical Inc

Imaging lesion localization marker, implantable

• Primary Device ID: 00850024195035
• NIH Device Record Key: 9f31b20b-9744-4c20-a858-5b8996948210
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOLLI
• Version Model Number: MM1000
• Company DUNS: 204044952
• Company Name: Molli Surgical Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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
GS1	00850024195028 [Primary]
GS1	00850024195035 [Package]; Contains: 00850024195028; Package: Shelf Carton [10 Units]; In Commercial Distribution
GS1	00850024195042 [Package]; Contains: 00850024195028; Package: Corrugate Box [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210600

FDA Product Code

• NEU: Marker, Radiographic, Implantable

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: 2021-09-06
• Device Publish Date: 2021-08-27

On-Brand Devices [MOLLI ]

• 00850024195035: MOLLI Introducer & MOLLI Marker (8 cm, 14GA) For use with the MOLLI System Note, the Introducer
• 00850024195011: MOLLI Tablet
• 00850024195004: MOLLI Wand
• 00850024195080: MOLLI Introducer and MOLLI Marker (12 cm, 14GA) For use with the MOLLI System Note, the Introduc
• 00850024195165: MOLLI re.markable (w/ 12cm Introducer) Single Unit
• 00850024195158: MOLLI 2 Tablet
• 00850024195141: MOLLI 2 Wand
• 00850024195172: MOLLI Pole Clamp
• 00850024195219: MOLLI OncoPen