FMsealer FM4001

GUDID 20859729006169

FMsealer Laparoscopic Shears - 5 mm Diameter / 36 cm Length

DOMAIN SURGICAL, INC.

Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use Electrosurgical handpiece, single-use

• Primary Device ID: 20859729006169
• NIH Device Record Key: 145a4b8e-5172-4287-aeda-640c5d4f465d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FMsealer
• Version Model Number: 4001
• Catalog Number: FM4001
• Company DUNS: 963249342
• Company Name: DOMAIN SURGICAL, INC.
• Device Count: 1
• 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: true
• Expiration Date: false
• 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	00859729006165 [Primary]
GS1	10859729006162 [Package]; Contains: 00859729006165; Package: Sterile Pouch [1 Units]; In Commercial Distribution
GS1	20859729006169 [Package]; Contains: 10859729006162; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142229

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [FMsealer]

• 20859729006169: FMsealer Laparoscopic Shears - 5 mm Diameter / 36 cm Length
• 20859729006152: FMsealer Open Shears