Signature

GUDID B33158630000

Tissue Grasper

SILEX MEDICAL, LLC

Laparoscopic grasping forceps, reusable

• Primary Device ID: B33158630000
• NIH Device Record Key: 87dd2ae5-826c-4b7c-bc5c-a9e72a1fb7e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signature
• Version Model Number: 5863000
• 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	B33158630000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914910

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[B33158630000]

Moist Heat or Steam Sterilization

[B33158630000]

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: 2017-12-28

On-Brand Devices [Signature]

• B3335851032: Blunt Grasping Forceps
• B331588109345: Locking Long Hunter Style Bowel Grasping Forceps
• B3315881093: Locking Hunter Style Bowel Grasping Forceps
• B331588109245: Locking Long 40MM Debakey Grasping Forceps
• B3315881092: Locking 40MM Debakey Grasping Forceps
• B331588108845: Locking Long Single Modified Allis Grasping Forceps
• B3315881088: Locking Single Modified Allis Grasping Forceps
• B331588108745: Locking Long Double Modified Allis Grasping Forceps
• B3315881087: Locking Double Modified Allis Grasping Forceps
• B3315881079: Locking 10MM Babcock Grasping Forceps
• B331588107245: Locking Long Cup Grasping Forceps
• B3315881072: Locking Cup Grasping Forceps
• B331588106945: Locking Long Cobra Tooth Grasping Forceps
• B3315881069: Locking Cobra Tooth Grasping Forceps
• B3315881068: Locking 10MM Mixter Dissecting Forceps
• B331588106745: Locking Long Maryland Dissecting Forceps
• B3315881067: Locking Maryland Dissecting Forceps
• B331588106645: Locking Long Mixter Dissecting Forceps
• B3315881066: Locking Mixter Dissecting Forceps
• B331588106345: Locking Long Right Angle Dissecting Forceps
• B3315881063: Locking Right Angle Dissecting Forceps
• B331588105645: Locking Long Single Action Retraction Grasping Forceps
• B3315881056: Locking Single Action Retraction Grasping Forceps
• B331588105345: Locking Long Atraumatic Grasping Forceps
• B3315881053: Locking Atraumatic Grasping Forceps
• B331588105145: Locking Long Single Action Wave Grasping Forceps
• B3315881051: Locking Single Action Wave Grasping Forceps
• B331588105045: Locking Long Fundus Tri-Max Grasping Forceps
• B3315881050: Locking Fundus Tri-Max Grasping Forceps
• B331588104545: Locking Long Needle Nose Dissecting Forceps
• B3315881045: Locking Needle Nose Dissecting Forceps
• B331588104445: Locking Long Micro-Fenestrated Grasping Forceps
• B3315881044: Locking Micro-Fenestrated Grasping Forceps
• B331588103545: Locking Long Cup Tooth Dissecting Forceps
• B3315881035: Locking Cup Tooth Dissecting Forceps
• B331588103445: Locking Long Dolphin Nose Dissecting Forceps With Tissue Well
• B3315881034: Locking Dolphin Nose Dissecting Forceps With Tissue Well
• B331588103345: Locking Long Bullet Nose Dissecting Forceps
• B3315881033: Locking Bullet Nose Dissecting Forceps
• B331588103245: Locking Long Blunt Grasping Forceps
• B3315881032: Locking Blunt Grasping Forceps
• B331588103045: Locking Long Dolphin Nose Grasping Forceps
• B3315881030: Locking Dolphin Nose Grasping Forceps
• B331588102445: Locking Long Fenestrated Straight Grasping Forceps
• B3315881024: Locking Fenestrated Straight Grasping Forceps
• B331588101845: Locking Long Retrograde Grasping Forceps
• B3315881018: Locking Retrograde Grasping Forceps
• B331588101245: Locking Long 90° Degree Right Angle Dissecting Forceps
• B3315881012: Locking 90° Degree Right Angle Dissecting Forceps
• B331588100745: Locking Long Flat Blunt Dissecting Forceps