FDA.reportPublic FDA data

INHANCE INTACT

Primary DI
10603295559696
Brand
INHANCE INTACT
Company
DEPUY (IRELAND)
Model
6231-31-303
Catalog number
623131303
Device description
INHANCE INTACT INSTRUMENT CASE COMPLETE
Published
2025-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSHTray, surgical, needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSHTray, Surgical, NeedleGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295559696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329555969610603295559696

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
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
10603295518761SMARTSET5450-45-5005450455002026-09-10
10603295168324SMARTSET3092-02030920202015-09-24
10603295168331SMARTSET3092-04030920402015-09-24
10603295168355SMARTSET3102-08031020802015-09-24
10603295168362SMARTSET3122-02031220202015-09-24
10603295168379SMARTSET3122-04031220402015-09-24
10603295168614NA3312-04033120402015-09-24
10603295168621NA3322-02033220202015-09-24
10603295168638NA3332-04033320402015-09-24
10603295174264NA5450-31-5005450315002015-09-24
10603295174271NA5450-32-5005450325002015-09-24
10603295174288SMARTSET5450-35-5005450355002015-09-24
10603295174295SMARTSET5450-50-5015450505012015-09-24
10603295202486SMARTMIX CEMVAC83-16038316032018-09-24
10603295541325ATTUNE1518-20-1051518201052021-08-27
10603295541332ATTUNE1518-20-1061518201062021-08-27
10603295541349ATTUNE1518-20-1071518201072021-08-27
10603295541356ATTUNE1518-20-1081518201082021-08-27
10603295541363ATTUNE1518-20-1101518201102021-08-27
10603295541370ATTUNE1518-20-1121518201122021-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295538806INHANCEDEPUY (IRELAND)FSH2026-05-01
10603295564102INHANCEDEPUY (IRELAND)FSH2026-05-01
10889942691678Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FSH2018-08-28
10889942746507Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FSH2018-08-28
10885403108563N/ACAREFUSION 2200, INCFSH2018-07-18
10885403247224N/ACAREFUSION 2200, INCFSH2018-07-18
50885403108561N/ACAREFUSION 2200, INCFSH2018-07-18
50885403247222N/ACAREFUSION 2200, INCFSH2018-07-18
10885403057243JamshidiCAREFUSION 2200, INCFSH2016-09-30
10885403057267JamshidiCAREFUSION 2200, INCFSH2016-09-30
10885403076152JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
10885403076169JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
10885403076176JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
10885403076190JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
10885403076206JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
10885403076213JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
10885403103186JamshidiCAREFUSION 2200, INCFSH2016-09-30
10885403108594JamshidiCAREFUSION 2200, INCFSH2016-09-30
10885403108600JamshidiCAREFUSION 2200, INCFSH2016-09-30
10885403108624JamshidiCAREFUSION 2200, INCFSH2016-09-30
10885403108662JamshidiCAREFUSION 2200, INCFSH2016-09-30
10885403108686JamshidiCAREFUSION 2200, INCFSH2016-09-30
10885403108693JamshidiCAREFUSION 2200, INCFSH2016-09-30
50885403076150JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
50885403076167JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
50885403076174JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
50885403076198JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
50885403076204JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
50885403076211JAMSHIDICAREFUSION 2200, INCFSH2016-09-30
50885403108592JamshidiCAREFUSION 2200, INCFSH2016-09-30