What is FDA product code FEB?

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Gastroenterology & Urology › DiagnosticAccessories, Cleaning, For Endoscope

Scope ID TAG

Name: Scope ID TAG
Brand: Scope ID TAG

Catalogue number MAJ-1545, listed by Olympus Medical Systems Corp., Japan, under Accessories, Cleaning, For Endoscope. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

5510(k) clearances naming this product code

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FEB
Manufacturer	City	Province	Registered as	Device types
Saint-Gobain Life Sciences (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	5

Record

Regulatory record for Scope ID TAG
Listed by	Olympus Medical Systems Corp., Japan
FDA product code	FEB
Device type	Accessories, Cleaning, For Endoscope
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Specification developer, Manufacturer, Exporter
Record published	2016-09-21
Record revised	2025-10-09 (version 10)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	High-level Disinfectant, Ethylene Oxide
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Scope ID TAG
Catalogue number	Size	Status
MAJ-1545		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medivators Hookup	Medivators Inc	333
Evotech™	Advanced Sterilization Products Services Inc.	104
Connecting Tube	Olympus Medical Systems Corp.	47
Accessories, Cleaning, For Endoscope	Steris Corporation	39
Accessories, Cleaning, For Endoscope	Pentax of America, Inc.	24
Accessories, Cleaning, For Endoscope	Richard Wolf Gmbh	16
ASP Aeroflex™	Advanced Sterilization Products Services Inc.	10
Scope Buddy Plus Tubing	Medivators Inc	9
Accessories, Cleaning, For Endoscope	Corporation Steris Canada	8
Scope Assist Flushing Sink (Safs)	Wassenburg Medical, Inc.	6
System 83 Plus	Wassenburg Medical, Inc.	4
Leak Test AIR Tube	Olympus Medical Systems Corp.	4

Showing 12 of 48. All products under Accessories, Cleaning, For Endoscope

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K201920	2020-09-01
K190969	2019-07-09
K120357	2012-12-20
K103264	2011-02-23
K093106	2010-02-12

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.