FDA.reportPublic FDA data

PITANGUY ABDOMINAL RETRACTOR

Primary DI
00192896080287
Brand
PITANGUY ABDOMINAL RETRACTOR
Company
SONTEC INSTRUMENTS, INC.
Model
475-920
Catalog number
475-920
Device description
PITANGUY ABDOMINAL RETRACTOR LARGE STRAIGHT BLADE
Published
2018-09-20
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
FFORETRACTOR, SELF-RETAINING
FGNRetractor, Non-Self-Retaining

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1
FGNRetractor, Non-Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896080287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896080287001928960802871928960802870192896080287

GMDN Terms#

Term, Definition table
TermDefinition
Externally-anchored laparoscopic retractorA non-sterile, intraoperative surgical instrument designed for use during laparoscopic procedures to provide hands-free retraction of lower abdominal, urogenital or pelvic structures. It is inserted into the abdominal cavity through a small dedicated incision and manoeuvred into place under direct laparoscopic vision to lift the urogenital structures, and then anchored external to the body to a fixation device typically attached to the operating table. It is typically made of metal (e.g., stainless steel) and is in the form of a rod shaped to form a saddle-shaped hook, and may be available in left and right configurations. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length190Millimeter

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam 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
09348811019394INKAThe Trustee for KAISER FAMILY TRUSTFGN2025-11-19
09348811019400INKAThe Trustee for KAISER FAMILY TRUSTFGN2025-11-19
09348811023612INKAThe Trustee for KAISER FAMILY TRUSTFFO2025-11-19
07898506814732QuinelatoSchobell Industrial LtdaFGN2023-01-09
07898506813698QuinelatoSchobell Industrial LtdaFFO2022-12-16
10381780268437Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-10-23
10381780268437Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-10-23
10381780268420Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780268420Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780268499Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-05-03
10381780268499Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-05-03
10381780268413Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268413Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268444Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268444Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268451Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268451Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268468Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268468Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268475Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268475Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268482Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268482Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268505Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268505Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268512Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268512Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268529Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFGN2018-02-23
10381780268529Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23
10381780268543Omni-Tract®INTEGRA LIFESCIENCES CORPORATIONFFO2018-02-23