FDA.reportPublic FDA data

Made-To-Order

Primary DI
00840338612656
Brand
Made-To-Order
Company
TORNIER, INC.
Model
9027479
Catalog number
9027479
Device description
Modified France Retractor
Published
2026-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00840338612656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840338612656008403386126568403386126560840338612656

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)494-7950customerservice@tornier.com

Regulatory Flags#

DUNS number
968990812
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846832085675TORNIER PERFORM™ REVERSEDDWJ1017304DWJ10173042022-01-05
00846832085682TORNIER PERFORM™ REVERSEDDWJ1017305DWJ10173052022-01-05
00846832085699TORNIER PERFORM™ REVERSEDDWJ1017306DWJ10173062022-01-05
00846832085705TORNIER PERFORM™ REVERSEDDWJ1017307DWJ10173072022-01-05
00846832085743TORNIER PERFORM™ REVERSEDDWJ1017204DWJ10172042022-01-05
00846832085750TORNIER PERFORM™ REVERSEDDWJ1017205DWJ10172052022-01-05
00846832085767TORNIER PERFORM™ REVERSEDDWJ1017206DWJ10172062022-01-05
00846832085774TORNIER PERFORM™ REVERSEDDWJ1017207DWJ10172072022-01-05
00846832085781TORNIER PERFORM™ REVERSEDDWJ1017701DWJ10177012022-01-05
00846832085798TORNIER PERFORM™ REVERSEDDWJ1017702DWJ10177022022-01-05
00846832085804TORNIER PERFORM™ REVERSEDDWJ1017703DWJ10177032022-01-05
00846832085811TORNIER PERFORM™ REVERSEDDWJ1017601DWJ10176012022-01-05
00846832085828TORNIER PERFORM™ REVERSEDDWJ1017602DWJ10176022022-01-05
00846832085835TORNIER PERFORM™ REVERSEDDWJ1017603DWJ10176032022-01-05
00846832092086Tornier Perform® Reversed Augmented GlenoidDWJ513DWJ5132022-05-10
00846832092093Tornier Perform® Reversed Augmented GlenoidDWJ503DWJ5032022-05-10
00846832092109Tornier Perform® Reversed Augmented GlenoidDWJ505DWJ5052022-05-10
00846832092123Tornier Perform® Reversed Augmented GlenoidDWJ502DWJ5022022-05-10
00846832092130Tornier Perform® Reversed Augmented GlenoidDWJ514DWJ5142022-05-10
00846832092147Tornier Perform® Reversed Augmented GlenoidDWJ515DWJ5152022-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840277134011Innomed, Inc.INNOMED, INC.GAD2026-10-22
00190776435615MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435622MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435660MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435707MillenniumAvalign Technologies, Inc.GAD2026-10-21
00190776435714MillenniumAvalign Technologies, Inc.GAD2026-10-21
00724995323998V. MuellerSTERIS Deutschland GmbHGAD2026-10-21
00190776435578MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776435585MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776437787MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776439699MilleniumAvalign Technologies, Inc.GAD2026-10-20
B382SD907310070Surgical DirectSurgical Direct, Inc.GAD2026-10-20
00190776435219MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435233MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435264MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435301MillenniumAvalign Technologies, Inc.GAD2026-10-19
03661219011590LANDANGERLANDANGERGAD2026-10-19
G4533310960PEAK MEDICALPeak Medical Distribution Inc.GAD2026-10-19
00198506056529ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096075ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096082ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096099ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00810111228480RetractorTreace Medical Concepts, Inc.GAD2026-10-16
00724995266936Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
00810130207572MSIModern Surgical Instruments LLCGAD2026-10-15
00810130207589MSIModern Surgical Instruments LLCGAD2026-10-15
00810220800645Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800652Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800669Adler Instrument CompanyAdler, Inc.GAD2026-10-15
03661219013341LANDANGERLANDANGERGAD2026-10-15