FDA.report

ELMED

Primary DI
00842180151901
Brand
ELMED
Company
ELMED INCORPORATED
Model
40-2221
Catalog number
40-2221
Device description
Low-Profile Dedo-Style Laser Laryngoscope, Adult is supplied with a single light carrier, flush with the handle, which accommodates a slim and lightweight blue Pilling fiberoptic cable (sold separately). Size Adult. Length 178mm, Min I.D. 10.7mm, Nominal Proximal Dims 19.0mm x 19.0mm, Max O.D. 25.5mm,
Published
2023-01-18
Public version status
Update
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
CCWLaryngoscope, Rigid

Product Code Classifications

CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842180151901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180151901008421801519018421801519010842180151901

GMDN Terms

TermDefinition
Rigid optical laryngopharyngoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the larynx/oropharynx. It is inserted into the body through the mouth during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle, or the device may allow for direct visualization through the lumen of its shaft/working channel. This device may be equipped with a channel or mechanism allowing the introduction of air to prevent misting of the distal end. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags

DUNS number
049290364
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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