FDA.reportPublic FDA data

Depuy Synthes

Primary DI
00190776028237
Brand
Depuy Synthes
Company
Avalign Technologies, Inc.
Model
03.520.015
Device description
Scissors, Gorney Style, Long, Curved
Published
2017-12-08
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
00190776028237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776028237001907760282371907760282370190776028237

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA non-dedicated, hand-held manual surgical instrument designed to cut a variety of tissues during open surgery; it is not dedicated to surgery at a specific anatomy/body orifice nor does it have a single clinical intended use. It might in addition be intended for cutting sutures or other materials associated with surgery. It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
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
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00846159039764SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27