LEEP Vaginal Electrode

GUDID 20888937010897

LEEP Vaginal Electrode; 8 cm Shaft; 15 Degree Bend

Coopersurgical, Inc.

Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use Open-surgery electrosurgical electrode, monopolar, single-use

Primary Device ID	20888937010897
NIH Device Record Key	65fd23bb-224b-4e9f-9e3c-2a532043cf3d
Commercial Distribution Status	In Commercial Distribution
Brand Name	LEEP Vaginal Electrode
Version Model Number	V1004
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	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

Device Dimensions

Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter
Depth	0.4 Centimeter
Width	1 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937010893 [Primary]
GS1	20888937010897 [Package] Contains: 00888937010893 Package: [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K905747

FDA Product Code

HGI	Electrocautery, Gynecologic (And Accessories)

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	2019-02-07
Device Publish Date	2016-08-15

Devices Manufactured by Coopersurgical, Inc.

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
00888937023824 - K-Systems	2024-02-27 L126 IVF, Standard Heat Right
00888937023831 - K-Systems	2024-02-27 L126 IVF, RI Witness Right