FDA.reportPublic FDA data

Cooley Mitral Retractor Frame

Primary DI
00192896116559
Brand
Cooley Mitral Retractor Frame
Company
SONTEC INSTRUMENTS, INC.
Model
2500-4750
Catalog number
2500-4750
Device description
Cooley Mitral Retractor Frame 205 Millimeter Spread x 230 Millimeter Arm Length XXL
Published
2024-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896116559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896116559001928961165591928961165590192896116559

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system mounting frame, reusableA noninvasive mounting device (e.g., a large ring, table-fixed bridging bar) designed as a component of a surgical retraction system, intended to be placed/fixed around a surgical incision site and upon which retraction system blades/components are mounted to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during surgery. It does not include the invasive retraction blades/components (i.e., is not the complete system). This is a reusable device.

Sterilization Methods#

Method table
Method
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
00192896117129Meeker Hemostatic Forceps2200-440Q2200-440Q2024-03-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275341Intrace USAPILOTIS TECH LLCGAD2026-07-03
00850083275570Intrace USAPILOTIS TECH LLCGAD2026-07-03
00850083275969Intrace USAPILOTIS TECH LLCGAD2026-07-03
00198506091339ELMED INCORPORATEDELMED INCORPORATEDGAD2026-06-09
00840277133670Innomed, Inc.INNOMED, INC.GAD2026-06-09
04049047155324GimmiGimmi GmbHGAD2026-06-08
G453PM1580030BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-06-08
00846159040524SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040531SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040548SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040555SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040562SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040579SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040586SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040593SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040609SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040616SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040623SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00841536147230ThompsonThompson Surgical Instruments, Inc.GAD2026-06-03
00846159040388SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040395SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040401SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040418SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040425SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040432SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040449SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040456SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040463SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040470SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03
00846159040487SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-03