FDA.report

AED 35MM Optical Coupler

Primary DI
00848657070935
Brand
AED 35MM Optical Coupler
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
CPL 35
Catalog number
CPL 35
Device description
Optical Coupler: The device is 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. This is a reusable device.
Published
2020-03-06
Public version status
New
Distribution status
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
FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)

Product Code Classifications

CodeDeviceSpecialtyClass
FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)Gastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848657070935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657070935008486570709358486570709350848657070935

GMDN Terms

TermDefinition
Endoscope camera adaptorA 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. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Ethylene Oxide

Contacts

PhoneEmail
8182272720customerservice@aed.md

Regulatory Flags

DUNS number
839138955
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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