FDA.reportPublic FDA data

Laryngeal Mirror

Primary DI
00192896110274
Brand
Laryngeal Mirror
Company
SONTEC INSTRUMENTS, INC.
Model
502-256Q
Device description
Laryngeal Mirror With Handle 28 Millimeter #7 Quantum
Published
2021-06-10
Public version status
Update
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
00192896110274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896110274001928961102741928961102740192896110274

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal mirror, reusableA hand-held manual 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, intended to be used for a laryngeal examination. The mirror is affixed at an angle to a 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 throat. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Inch

Sterilization Methods#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896103603ROCHESTER CARMALT FORCEPS1100-151Q1100-151Q2020-07-23
00192896038110SONTEC-MICHELE TREPHINE419-392419-3922018-09-11
00192896038127SONTEC-MICHELE TREPHINE419-393419-3932018-09-11
00192896038134SONTEC-MICHELE TREPHINE419-394419-3942018-09-11
00192896038141SONTEC-MICHELE TREPHINE419-395419-3952018-09-11
00192896038158SONTEC-MICHELE TREPHINE419-396419-3962018-09-11
00192896038165SONTEC-MICHELE TREPHINE419-397419-3972018-09-11
00192896038172SONTEC-MICHELE TREPHINE419-398419-3982018-09-11
00192896094710INGE LAMINA SPREADER RETRACTOR417-056417-0562019-03-07
00192896123427Trocar20910-1120910-112026-06-02
00192896123434Flexible Trocar Sleeve15-16141-0315-16141-032026-06-02
00192896123441Barraquer Anis Needle Holder15-3810Q15-3810Q2026-06-02
00192896105553Rochester Carmalt Forceps1100-1541100-1542020-11-16
00192896105591Bone Tamp335-400335-4002020-11-18
00192896105607Bone Tamp335-404335-4042020-11-18
00192896102637Carmalt Forceps1100-152L1100-152L2020-06-15
00192896101524BONE TAMP1103-197A1103-197A2020-05-11
00192896099715WILDE ETHMOID RONGEUR468-622468-6222018-09-20
00192896094109ROCHESTER CARMALT FORCEPS1100-153Q1100-153Q2019-03-07
00192896094475ROCHESTER CARMALT FORCEPS1100-152Q1100-152Q2019-03-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770426027Bausch + LombBausch & Lomb IncorporatedKAI2026-04-30
00757770457601Bausch + LombBausch & Lomb IncorporatedKAI2026-04-30
00190776420017MillenniumAvalign Technologies, Inc.KAI2026-04-15
00190776419165MillenniumAvalign Technologies, Inc.KAI2026-04-13
00190776417642MillenniumAvalign Technologies, Inc.KAI2026-03-04
00190776415709MillenniumAvalign Technologies, Inc.KAI2026-02-04
09348811109620INKAThe Trustee for KAISER FAMILY TRUSTKAI2025-11-25
00190776413286MillenniumAvalign Technologies, Inc.KAI2025-10-09
04250676710079Atticus mirrorSpiggle & Theis Medizintechnik GmbHKAI2025-09-25
04250676718006Mirror, round, polishedSpiggle & Theis Medizintechnik GmbHKAI2025-09-19
00194613011741MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011758MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011772MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011789MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
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00194613049515MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613103385MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00757770402847Bausch + LombBausch & Lomb IncorporatedKAI2025-07-28
00757770405664Bausch + LombBausch & Lomb IncorporatedKAI2025-07-28
00757770409273Bausch + LombBausch & Lomb IncorporatedKAI2025-07-28