FDA.reportPublic FDA data

EPISIOTOMY SCISSORS

Primary DI
00192896097032
Brand
EPISIOTOMY SCISSORS
Company
SONTEC INSTRUMENTS, INC.
Model
525-546
Catalog number
525-546
Device description
EPISIOTOMY SCISSORS CURVED TO SIDE BLADE POWERCUT GOLD
Published
2019-05-09
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
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896097032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896097032001928960970321928960970320192896097032

GMDN Terms#

Term, Definition table
TermDefinition
Episiotomy scissors, reusableA hand-held, manual, obstetrical, surgical instrument intended to cut the outlet of the vagina in childbirth so as to facilitate the birth of the child (also known as perineotomy). It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes; the blades are typically angled, have different shapes, and may be serrated. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Inch

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
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
00192896056282ALLIGATOR FORCEPS1271-0101271-0102018-09-27
00192896123755Debakey-Diethrich Tissue Forceps442-239P442-239P2026-09-18
00192896123762TAVR Removal Set2400-200-SET2400-200-SET2026-09-18
00192896123779Waever Chalazion Forceps14-988014-98802026-09-18
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
00192896123670Meyerding Finger Retractor205-857Q205-857Q2026-08-27
00192896122499Cartilage Graft Cutter350-842350-8422025-11-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995268848Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268855Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268862Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268879Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268886Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268893Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268909Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00190776432355MillenniumAvalign Technologies, Inc.LRW2026-09-24
00810238290001PRINCETONPrinceton Medical Group, Inc.LRW2026-09-22
00190776427979MillenniumAvalign Technologies, Inc.LRW2026-08-27
00190776428013MillenniumAvalign Technologies, Inc.LRW2026-08-27
00190776428136MillenniumAvalign Technologies, Inc.LRW2026-08-27
00190776428204MillenniumAvalign Technologies, Inc.LRW2026-08-27
00190776428235MillenniumAvalign Technologies, Inc.LRW2026-08-27
00192896123649Converse ScissorsSONTEC INSTRUMENTS, INC.LRW2026-08-27
00192896123656Ferguson Abdominal ScissorsSONTEC INSTRUMENTS, INC.LRW2026-08-27
00190776423865MillenniumAvalign Technologies, Inc.LRW2026-08-26
00190776423872MillenniumAvalign Technologies, Inc.LRW2026-08-26
00190776427634MillenniumAvalign Technologies, Inc.LRW2026-08-26
00846159040845SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-08-26
00846159040852SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-08-26
00846159040869SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-08-26
00190776420383MillenniumAvalign Technologies, Inc.LRW2026-08-25
04058749006032NAFehling Instruments GmbH & Co. KGLRW2026-08-25
04058749047219NAFehling Instruments GmbH & Co. KGLRW2026-08-25
00190776427283MillenniumAvalign Technologies, Inc.LRW2026-08-21
04054462903290evonosevonos GmbH & Co. KGLRW2026-08-21
04054462904624evonosevonos GmbH & Co. KGLRW2026-08-21
04054462904631evonosevonos GmbH & Co. KGLRW2026-08-21
04054462904655evonosevonos GmbH & Co. KGLRW2026-08-21