FDA.reportPublic FDA data

RETAINING STRAP

Primary DI
00192896071230
Brand
RETAINING STRAP
Company
SONTEC INSTRUMENTS, INC.
Model
C-000.32.305
Catalog number
C-000.32.305
Device description
RETAINING STRAP FOR S-FRAME
Published
2018-09-17
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
FSPLOUPE, DIAGNOSTIC/SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSPLoupe, Diagnostic/SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896071230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896071230001928960712301928960712300192896071230

GMDN Terms#

Term, Definition table
TermDefinition
LoupeA convex lens with an built-in, electrical light source used for magnifying vision and concentrating the light upon an object or objects being viewed. It can be used for a variety of purposes, e.g., the examination of an object for laboratory work, diagnosis, minor surgery, dermatology, or by persons with a strong eyesight impairment. The loupe is typically mounted on the end of an adjustable arm (e.g., a flexible tube or an articulating arm) which is attached to a stable base or clamped to a surface worktop.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896044661BARR PROBE508-547508-5472018-09-14
00192896123397Smithwick Vasectomy Hook516-716516-7162026-05-12
00192896123373Skinner Tissue Forceps140-376H140-376H2026-05-11
00192896123380Biopsy Punch2901-117L2901-117L2026-05-11
00192896123403Mictec High Frequency Cable26944-3226944-322026-05-11
00192896123410Biopsy Cup2901-125L2901-125L2026-05-11
00192896112193HU Capsular Polisher12-268512-26852022-02-03
00192896025929MEYERDING RETRACTOR207-411207-4112018-09-12
00192896025936MEYERDING RETRACTOR207-413207-4132018-09-12
00192896025943MEYERDING RETRACTOR207-415207-4152018-09-12
00192896100671TEALES GORGET SPECULUM516-506516-5062025-02-24
00192896118003Reynolds Tenotomy Scissors2405-329B2405-329B2024-06-21
00192896115750Teales Gorget SpeculumT516-507T516-5072023-11-03
00192896099753LUXATOR ELEVATOR1100-586S11100-586S12018-09-21
00192896015272ENUCLEATION SCISSORS13-980513-98052018-09-13
00192896015289ENUCLEATION SCISSORS13-981013-98102018-09-13
00192896015296ENUCLEATION SCISSORS13-982013-98202018-09-13
00192896017214CASTROVIEJO LIP GRAFT CLAMP FORCEPS14-972514-97252018-09-17
00192896081635LUXATOR ELEVATOR1100-586C11100-586C12018-09-21
00192896081642LUXATOR ELEVATOR1100-586C21100-586C22018-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850036373377Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373384Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373391Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373407Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373414Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373421Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373438Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373445Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373452Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00723896025321TTL Easy Size 2.5X Loupes RedPRACTICON, INC.FSP2026-01-07
00723896025338TTL Easy Size 3.0X Loupes RedPRACTICON, INC.FSP2026-01-07
00723896025505TTL Easy Size 2.5X Loupes SilverPRACTICON, INC.FSP2026-01-07
00723896025512TTL Easy Size 3.0X Loupes SilverPRACTICON, INC.FSP2026-01-07
00723896030097TTL Easy Size 2.5X Loupes BlackPRACTICON, INC.FSP2026-01-07
00723896030103TTL Easy Size 3.0X Loupes BlackPRACTICON, INC.FSP2026-01-07
00850036373902ErgoZoom™ PlanoMETREX RESEARCH, LLCFSP2025-07-21
00850036373919ErgoZoom™ RxMETREX RESEARCH, LLCFSP2025-07-21
00850036373926ErgoZoom™ Plano - Dragonfly™METREX RESEARCH, LLCFSP2025-07-21
00850036373933ErgoZoom™ Rx - Dragonfly™METREX RESEARCH, LLCFSP2025-07-21
00810186670054Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670061Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670078Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670085Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670092Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670108Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670115Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00810186670122Enova IlluminationEnova Illumination, Inc.FSP2025-05-28
00615375010129Universal Flip - PlanoMETREX RESEARCH, LLCFSP2025-04-30
00615375010136Universal Flip - RxMETREX RESEARCH, LLCFSP2025-04-30
00615375014493Dragonfly™ - Headlight only - PlanoMETREX RESEARCH, LLCFSP2025-04-30