LEEP Square Condyloma Electrode

GUDID 20888937010866

LEEP Square Condyloma Electrode 5.5cm Shaft; 15 Degree Bend

Coopersurgical, Inc.

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Primary Device ID	20888937010866
NIH Device Record Key	c1ea6585-a119-4d24-ab0d-78af5a3a3f4c
Commercial Distribution Status	In Commercial Distribution
Brand Name	LEEP Square Condyloma Electrode
Version Model Number	S1004
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	00888937010862 [Primary]
GS1	20888937010866 [Package] Contains: 00888937010862 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

On-Brand Devices [LEEP Square Condyloma Electrode]

20888937010873	LEEP Square Condyloma Electrode; 5.5cm Shaft; 15 Degree Bend
20888937010866	LEEP Square Condyloma Electrode 5.5cm Shaft; 15 Degree Bend