LEISEGANG

GUDID 00888937013016

OPTIK Model 1 Colposcope; 3 MAG Non-Photo Swing Scope

Coopersurgical, Inc.

Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope Colposcope

• Primary Device ID: 00888937013016
• NIH Device Record Key: c505810f-af90-405d-b59a-e56290d39c31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEISEGANG
• Version Model Number: OPTIK1-02
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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: false
• Lot Batch: false
• 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
GS1	00888937013016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140754
• Premarket Notification: K940094

FDA Product Code

• HEX: Colposcope (And Colpomicroscope)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-29

On-Brand Devices [LEISEGANG]

• 60888937009974: LM-900 CO2 Cryosurgery System. Contents: 1 Cryogun, replacement O-rings, cleaning plugs and gas
• 60888937009967: LM-900 N2O Cryosurgery System. Contents: 1 Cryogun, replacement O-rings, cleaning plugs and gas
• 00888937013146: OPTIK Model 2 Colposcope; Integrated Analog Video Swing Scope with LCD
• 00888937013139: OPTIK Model 2 Colposcope; Integrated Analog Video Swing Scope
• 00888937013122: OPTIK Model 2 Colposcope; Integrated Analog Video Upright Scope with LCD
• 00888937013115: OPTIK Model 2 Colposcope; Integrated Analog Video Upright Scope
• 00888937013108: OPTIK Model 2 Colposcope; Integrated Analog Video Tilt Scope with LCD
• 00888937013092: OPTIK Model 2 Colposcope; Integrated Analog Video Tilt Scope
• 00888937013085: OPTIK Model 2 Colposcope; 3 MAG 0.5" CCD Optimized Photo Swing Scope with Infinity Camera
• 00888937013078: OPTIK Model 2 Colposcope; 3 MAG 1.0" Photo B-O-M Scope with Canon dSLR Kit
• 00888937013061: OPTIK Model 2 Colposcope; 3 MAG 1.0" Photo B-O-M Scope
• 00888937013054: OPTIK Model 2 Colposcope; 3 MAG 1.0" Photo Swing Scope
• 00888937013047: OPTIK Model 2 Colposcope; 3 MAG 1.0" Photo Upright Scope with Canon dSLR Kit
• 00888937013030: OPTIK Model 2 Colposcope; 3 MAG 1.0" Photo Upright Scope
• 00888937013023: OPTIK Model 1 Colposcope; 3 MAG Non-Photo B-O-M Scope
• 00888937013016: OPTIK Model 1 Colposcope; 3 MAG Non-Photo Swing Scope
• 00888937013009: OPTIK Model 1 Colposcope; 3 MAG Non-Photo Upright Scope
• 00888937012996: OPTIK Model 1 Colposcope; 3 MAG non-Photo Tilt scope
• 00888937000085: OPTIK Model 2 Colposcope; 3 MAG 1.0" Photo Swing Scope with Canon dSLR Kit