FDA.reportPublic FDA data

MICHEL RHINOSCOPIC MIRROR

Primary DI
00192896094505
Brand
MICHEL RHINOSCOPIC MIRROR
Company
SONTEC INSTRUMENTS, INC.
Model
502-202
Catalog number
502-202
Device description
MICHEL RHINOSCOPIC MIRROR #2
Published
2019-05-03
Public version status
Update
Distribution status
Not 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
00192896094505PrimaryGS10
00192896097421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896094505001928960945051928960945050192896094505
00192896097421001928960974211928960974210192896097421

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
Length16Millimeter

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Dry Heat Sterilization
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-821-7496info@sontecinstruments.com
+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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00192896123786Prince Trachoma Eye Forceps14-968014-96802026-09-18
00192896123632Adson Dressing Forceps140-299S140-299S2026-08-27
00192896123649Converse Scissors460-156L460-156L2026-08-27
00192896123656Ferguson Abdominal Scissors110-287110-2872026-08-27
00192896123663Meyerding Finger Retractor205-856Q205-856Q2026-08-27
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00192896122048Ceramitec Universal Klick Ferris Smith Rongeur Shaft404-312B404-312B2026-08-25
00192896123564Castroviejo Corneal Scissors13-2540F13-2540F2026-07-27
00192896123571Adson Needle Holding Forceps140-300140-3002026-07-27
00192896123557Debakey Neonatal Clamp2100-580B2100-580B2026-07-10
00192896078819FERRIS-SMITH KERRISON404-682404-6822018-09-20
00192896117129Meeker Hemostatic Forceps2200-440Q2200-440Q2024-03-25
00192896123502Stefan Bone Holding Forceps1103-011Q1103-011Q2026-06-24
00192896123519Rochester Carmalt Forceps1100-150L1100-150L2026-06-24
00192896123526Rochester Carmalt Forceps1100-150LQ1100-150LQ2026-06-24

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