FDA.reportPublic FDA data

Michel Rhinoscopic Laryngeal Mirror

Primary DI
00192896097414
Brand
Michel Rhinoscopic Laryngeal Mirror
Company
SONTEC INSTRUMENTS, INC.
Model
502-201
Catalog number
502-201
Device description
Michel Rhinoscopic Laryngeal Mirror 14 Millimeter Tip Size 1
Published
2025-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KAIMIRROR, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAIMirror, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896097414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896097414001928960974141928960974140192896097414

GMDN Terms#

Term, Definition table
TermDefinition
Rhinoscopic mirrorA hand-held surgical instrument with a mirror or a surface sufficiently polished to reflect enough undiffused light to form a virtual image of an object placed before it at the distal end used for a rhinoscopic examination. The mirror is affixed to a very long, slender shaft with a handle at the proximal end that is held by the doctor who can manipulate the mirror close to the site of interest in the nose. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length11.5Inch

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

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