Silex

GUDID B331ONX1053L0

Locking Atraumatic Double Action Grasping Forceps

SILEX MEDICAL, LLC

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: B331ONX1053L0
• NIH Device Record Key: dad111dd-4026-432e-baa6-a0aec0063b52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silex
• Version Model Number: ONX-1053L
• Company DUNS: 362145604
• Company Name: SILEX MEDICAL, LLC
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• 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
HIBCC	B331ONX1053L0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914910

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[B331ONX1053L0]

Moist Heat or Steam Sterilization

[B331ONX1053L0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-09

On-Brand Devices [Silex]

• B331PLT2020: Hook Scissor
• B331PLT2006: Curved Metzenbaum Scissor
• B331PLT1093L45: Locking Long Hunter Style Bowel Grasping Forceps
• B331PLT1093L0: Locking Hunter Style Bowel Grasper
• B331PLT1091L0: Locking Debakey Grasping Forceps
• B331PLT1089L0: Locking Babcock Grasping Forceps
• B331PLT1089: Babcock Grasping Forceps
• B331PLT1079L0: Babcock Grasping Forceps
• B331PLT1078L0: Locking Allis Grasping Forceps
• B331PLT1078: Allis Grasping Forceps
• B331PLT1075: Biopsy Punch
• B331PLT107145: Long Spoon Biopsy Punch
• B331PLT1068: Mixter Dissecting Forceps
• B331PLT1067L0: Locking Maryland Dissector
• B331PLT1067: Maryland Dissector Forceps
• B331PLT1063: Right Angle Dissecting Forceps
• B331PLT1053L0: Locking Atraumatic Double Action Grasping Forceps
• B331PLT1053: Atraumatic Double Action Grasping Forceps
• B331PLT1052L45: Long Alligator Grasping Forceps
• B331PLT1052L0: Locking Alligator Grasping Forceps
• B331PLT1051L45: Locking Long Atraumatic Grasping Forceps
• B331PLT1051L0: Wave Grasping Forceps
• B331PLT1045: Needle Nose Dissecting Forceps
• B331PLT1035L0: Locking Cup Tooth Grasping Forceps
• B331PLT1028L0: Locking Endoclinch Grasper
• B331PLT1024L45: Locking Long Fenestrated Grasping Forceps
• B331PLT1024L0: Locking Fenestrated Grasper
• B331PLT1024: Fenestrated Grasping Forceps
• B331PLT1007: Flat Blunt Dissecting Forceps
• B331PLT1006L0: Locking Sharp Toothed Grasping Forceps
• B331PLT1002L0: Locking Gallbladder Grasping Forceps
• B331ONX2020: Hook Scissor
• B331ONX2006: Curved Metzenbaum Scissor
• B331ONX1089L0: Locking Babcock Grasping Forceps
• B331ONX1069L0: Locking Cobra Tooth Grasping Forceps
• B331ONX1068: Mixter Dissecting Forceps
• B331ONX1067L0: Locking Maryland Dissecting Forceps
• B331ONX1067: Maryland Dissecting Forceps
• B331ONX1063: Right Angle Dissecting Forceps
• B331ONX1056L45: Locking Long Single-Action Retraction Grasping Forceps
• B331ONX1056L0: Locking Single-Action Retraction Grasping Forceps
• B331ONX1056: Single-Action Retraction Grasping Forceps
• B331ONX1053L0: Locking Atraumatic Double Action Grasping Forceps
• B331ONX1051L0: Locking Wave Grasping Forceps
• B331ONX1037L0: Locking Stone Cup Grasping Forceps
• B331ONX1035L0: Locking Cup Tooth Grasping Forceps
• B331ONX1032L0: Locking Blunt Grasping Forceps
• B331ONX1024L45: Locking Long Fenestrated Grasping Forceps
• B331ONX1024L0: Locking Fenestrated Grasping Forceps
• B331ONX1015: Claw Grasping Forceps