Sani-Scope

GUDID 50888937013653

Sani-Scope® Disposable Anoscope

Coopersurgical, Inc.

Anoscope, single-use
Primary Device ID50888937013653
NIH Device Record Key7258bdf2-d4c0-4933-a5d0-3f84c70ed23a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSani-Scope
Version Model Number82420
Company DUNS801895244
Company NameCoopersurgical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS120888937013652 [Package]
Package: [4 Units]
In Commercial Distribution
GS150888937013653 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIBSpeculum, Vaginal, Nonmetal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by Coopersurgical, Inc.

00888937018240 - Lone Star® IRI Delivery2024-07-01 Lone Star® IRI Delivery Tube Replacement
00888937026597 - LEEP PRECISION™ Smoke Evacuator2024-06-25 LEEP PRECISION™ Smoke Evacuator (230 VAC)
60888937027176 - ERPeak2024-04-18 IVD Sample kit
60888937027183 - ERPeak2024-04-18 IVD Sample kit
60888937027190 - ERPeak2024-04-18 IVD Sample kit
60888937027206 - ERPeak2024-04-18 IVD Sample kit
00888937026870 - Mara Console2024-03-21 Mara Console- Endometrial Ablation
00888937023817 - K-Systems2024-02-27 L126 IVF, Standard Heat Right

Trademark Results [Sani-Scope]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SANI-SCOPE
SANI-SCOPE
75378046 2205687 Live/Registered
COOPERSURGICAL, INC.
1997-10-23
SANI-SCOPE
SANI-SCOPE
72162073 0762086 Dead/Expired
GENE BURNETT
1963-02-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.