FDA.report

460H

Primary DI
03596010539366
Brand
460H
Company
Smith & Nephew, Inc.
Model
72200091
Catalog number
72200091
Device description
CAMERA HEAD ANGLED PAL 460H
Published
2015-08-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FETEndoscopic video imaging system/component, gastroenterology-urology

Product Code Classifications

CodeDeviceSpecialtyClass
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010539366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03596010539366035960105393663596010539366

GMDN Terms

TermDefinition
Endoscope camera adaptorAn optical device designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. It may be referred to as a coupler. This is a reusable device.

Sterilization Methods

Method
Hydrogen Peroxide

Contacts

PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags

DUNS number
109903521
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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04953170437724Channel plugOLYMPUS MEDICAL SYSTEMS CORP.FET2023-04-22
04953170437731Injection tubeOLYMPUS MEDICAL SYSTEMS CORP.FET2023-04-22
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04953170437922Channel Connection TubeOLYMPUS MEDICAL SYSTEMS CORP.FET2023-04-22
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