LEISEGANG

GUDID 00888937013016

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

Coopersurgical, Inc.

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