ETHICON VSTL35

GUDID 20705031462578

Laparoscopic Dual Rigid Applicator

ETHICON INC.

Haematological concentrate/haemostatic agent cannula, endoscopic, single-use

• Primary Device ID: 20705031462578
• NIH Device Record Key: 093856ec-6f96-42df-83f7-7ae2ff44df1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ETHICON
• Version Model Number: VSTL35
• Catalog Number: VSTL35
• Company DUNS: 002144145
• Company Name: ETHICON 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: false
• 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

Customer Support Contacts

• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031462571 [Primary]
GS1	20705031462578 [Package]; Contains: 10705031462571; Package: BOX [3 Units]; In Commercial Distribution
GS1	30705031462575 [Package]; Contains: 10705031462571; Package: CASE [72 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK190324

FDA Product Code

• MZM: Fibrin sealant preparation device

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: 2019-10-09
• Device Publish Date: 2019-10-01

On-Brand Devices [ETHICON]

• 20705031240466: Evicel Laparoscopic Airless Spray Accessory
• 20705031230139: Evicel Airless Spray Accessory
• 20705031147833: EVICEL 4CM CONTROL TIP (SET OF 10)
• 20705031131955: Surgiflo Endoscopic Appicator
• 10705031007239: EVICEL 5 ML DEVICE
• 10705031007215: EVICEL 1/2 ML DEVICE
• 20705031005089: EVICEL 45CM FLEXIBLE TIP (SET OF 3)
• 20705031005072: EVICEL 35 CM APPLICATOR TIP
• 30705031238903: Pull-out Suture Set Surgical Steel w/ Monofilament 316L Stainless Steel 4-0 8" Loop
• 20705031036823: BONE WAX
• 30705031462728: Laparoscopic Dual Flexible Applicator
• 20705031462578: Laparoscopic Dual Rigid Applicator
• 20705031462530: VISTASEAL DUAL APPLICATOR
• 30705031050413: Chromic Suture Chromic Monofilament
• 30705031028962: Chromic Gut, Sterile, Absorbable Surgical Suture
• 10705031228139: CO2 Pressure Regulator