FMsealer FM3001

GUDID 20859729006152

FMsealer Open Shears

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: 20859729006152
• NIH Device Record Key: dc8fc200-c90c-4f11-bedd-8f3ab99ee3fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FMsealer
• Version Model Number: 3001
• Catalog Number: FM3001
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859729006158 [Primary]
GS1	10859729006155 [Package]; Contains: 00859729006158; Package: Sterile Pouch [1 Units]; In Commercial Distribution
GS1	20859729006152 [Package]; Contains: 10859729006155; Package: Box [5 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-06-15

On-Brand Devices [FMsealer]

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