FDA.report

INTUITION

Primary DI
10603295544579
Brand
INTUITION
Company
DEPUY (IRELAND)
Model
2525-30-400
Catalog number
252530400
Device description
INTUITION FOR HP PARTIAL FEMORAL FINISHING BLOCK SIZE - LEFT MEDIAL/RIGHT LATERAL 4
Published
2022-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTZINSTRUMENT, CUTTING, ORTHOPEDIC

Product Code Classifications

CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10603295544579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1060329554457910603295544579

GMDN Terms

TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags

DUNS number
989365556
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

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10603295085980GLOBAL UNITE2100-70-2502100702502018-06-15
10603295088196GLOBAL ADVANTAGE2128-02-0502128020502018-09-24
10603295130192ATTUNE2544-01-0032544010032018-09-24
10603295130208ATTUNE2544-01-0042544010042018-09-24
10603295130222ATTUNE2544-01-0062544010062018-09-24
10603295395423ATTUNE2544-01-0092544010092018-09-24
10603295431275DEPUY REACH9505-05-1349505051342018-09-24
10603295431596DEPUY REACH9505-05-1359505051352018-09-24
10603295440222ATTUNE2546-00-4242546004242016-12-05
10603295443780ATTUNE2544-91-0012544910012020-06-11
10603295443797ATTUNE2544-91-0022544910022020-06-11
10603295443803ATTUNE2544-91-0032544910032020-06-11
10603295443810ATTUNE2544-91-0042544910042020-06-11
10603295451297ATTUNE2546-00-4162546004162016-12-05
10603295493549ATTUNE2544-11-0032544110032017-04-10
10603295496229ATTUNE2546-00-5162546005162018-01-24
10603295543879RECLAIM74-1000-1157410001152026-01-23
10603295543916RECLAIM74-1000-1207410001202026-01-23
10603295503309ATTUNE1506-61-3101506613102026-01-13
10603295503316ATTUNE1506-61-3201506613202026-01-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810212930497SURGIPROSSurgipros, LLCHTZ2026-05-22
10603295553625ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
10603295553632ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
10603295553649ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
10603295553656ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-02-17
00190376538945Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00190376538952Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00190376700885Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00190376700892Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTZ2026-02-10
00840180544709General InstrumentsALPHATEC SPINE, INC.HTZ2026-01-29
00840180544716General InstrumentsALPHATEC SPINE, INC.HTZ2026-01-29
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10603295553687ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
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10603295553700ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
10603295554929ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2025-12-19
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00196449033584Anatomic Access LLIFTyber Medical, LLCHTZ2025-12-02
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