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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898789390053KAYE FREEMAN FACE-LIFT SCISSORS CURVED 23CMTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDALRW2026-06-09
00810055251520Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810055251537Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450714Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450721Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450738Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450752Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450998Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451018Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451032Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451056Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451070Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451513Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451568Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451728Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451735Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810220800317Adler Instrument CompanyAdler, Inc.LRW2026-06-02
00810220800331Adler Instrument CompanyAdler, Inc.LRW2026-06-02
00810220800355Adler Instrument CompanyAdler, Inc.LRW2026-06-02
00810220800362Adler Instrument CompanyAdler, Inc.LRW2026-06-02
09348811115461INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-06-02
00810143908329SURGIPROSSurgipros, LLCLRW2026-06-01
00810212930688SURGIPROSSurgipros, LLCLRW2026-06-01
B356BK211110American MedicalsAmerican MedicalsLRW2026-05-29
00846159039702SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039719SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039726SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039733SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039740SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039757SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27