REFLEX 16162

GUDID 10653405034971

REFLEX STR SURGICAL TROCAR SLEEVE 10/11MM

Conmed Corporation

Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use

• Primary Device ID: 10653405034971
• NIH Device Record Key: a392109c-6236-4b18-86bd-4fbd6f47608a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REFLEX
• Version Model Number: 16162
• Catalog Number: 16162
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• 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(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10653405034971 [Primary]
GS1	20653405034978 [Package]; Package: BOX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924761

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-09
• Device Publish Date: 2016-09-24

On-Brand Devices [REFLEX]

• 20653405074813: REFLEX ELC Endoscopic Clip Applier W/Titanium Clips, 10mm
• 10653405035206: REFLEX STR BLADED/SHIELDED SURGICAL TROCAR WITH UNIVERSAL CONVERTER 5/11MM
• 10653405035176: REFLEX 5/12MM UNIVERSAL CONVERTER
• 10653405035008: REFLEX STR BLADED/SHIELDED SURGICAL TROCAR 10/12MM
• 10653405034995: REFLEX STR BLADED/SHIELDED SURGICAL TROCAR WITH UNIVERSAL CONVERTER 5/12MM
• 10653405034971: REFLEX STR SURGICAL TROCAR SLEEVE 10/11MM
• 10653405034957: REFLEX STR SURGICAL TROCAR SLEEVE 5MM
• 10653405034940: REFLEX STR SURGICAL TROCAR SLEEVE 10/12MM
• 10653405034926: REFLEXT STR BLUNT TIP SURGICAL TROCAR 10/11MM
• 10653405034919: REFLEX STR BLADED/SHIELDED SURGICAL TROCAR 5MM
• 10653405034896: REFLEX STR BLADED/SHIELDED SURGICAL TROCAR 10/11MM
• 10653405034636: REFLEX STR BLADED/SHIELDED SURGICAL TROCAR 10/12MM LONG
• 20653405037108: REFLEX EXTRACTOR WIDE/REGULAR 12/CASE
• 10653405050896: Reflex TL, Skin Stapler with tissue lift, 35 regular
• 10653405050605: Reflex TL, Skin Stapler with tissue lift, 35 wide
• 10653405050599: Reflex One, Skin Stapler, 35 regular
• 10653405048381: Reflex One, Skin Stapler, 35 wide
• 10653405037019: Reflex TL, Skin Stapler with tissue lift, 35 wide
• 10653405036982: Reflex TL, Skin Stapler with tissue lift, 35 regular
• 10653405036951: Reflex One, Skin Stapler, 35 wide
• 10653405036920: Reflex One, Skin Stapler, 35 regular
• 00653405037258: REFLEX TL SKIN STAPLER WITH TISSUE LIFT, 35 WIDE: FURTHER PROCESSING REQUIRED
• 00653405037234: REFLEX ONE SKIN STAPLER, 35 WIDE: FURTHER PROCESSING REQUIRED
• 10653405035152: REFLEX 5MM SITE STABILITY DEVICE
• 10653405035138: REFLEX 10/12MM SITE STABILITY DEVICE
• 10653405035114: REFLEX 10/11MM SITE STABILITY DEVICE
• 10653405035190: CONVERTER 5MM SINGLE-USE