LEISEGANG OptiK® Model 2 Colposcope
GUDID 00888937019933
LEISEGANG OptiK® Model 2 Colposcope 3 MAG 1.0" Photo B-O-M Scope
Coopersurgical, Inc.
Colposcope| Primary Device ID | 00888937019933 |
| NIH Device Record Key | 7e342679-3043-415f-8d7f-43573395daba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LEISEGANG OptiK® Model 2 Colposcope |
| Version Model Number | DMOPTIK2-05 |
| 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 | 00888937019933 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- 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 | 2017-09-28 |
Devices Manufactured by Coopersurgical, Inc.
| 00888937018240 - Lone Star® IRI Delivery | 2024-07-01 Lone Star® IRI Delivery Tube Replacement |
| 00888937026597 - LEEP PRECISION™ Smoke Evacuator | 2024-06-25 LEEP PRECISION™ Smoke Evacuator (230 VAC) |
| 60888937027176 - ERPeak | 2024-04-18 IVD Sample kit |
| 60888937027183 - ERPeak | 2024-04-18 IVD Sample kit |
| 60888937027190 - ERPeak | 2024-04-18 IVD Sample kit |
| 60888937027206 - ERPeak | 2024-04-18 IVD Sample kit |
| 00888937026870 - Mara Console | 2024-03-21 Mara Console- Endometrial Ablation |
| 00888937023817 - K-Systems | 2024-02-27 L126 IVF, Standard Heat Right |
Trademark Results [LEISEGANG OptiK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LEISEGANG OPTIK 77579984 3612321 Live/Registered |
CooperSurgical, Inc. 2008-09-26 |
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