FDA.reportPublic FDA data

ACETABULAR REAMER D49 mm HC

Primary DI
08055727370259
Brand
ACETABULAR REAMER D49 mm HC
Company
HPF SRL
Model
9057.20.949
Published
2022-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055727370259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055727370259080557273702598055727370259

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular orthopaedic reamerAn orthopaedic surgical instrument designed to cut and resurface with precision the acetabulum for the acceptance of the acetabular component of a hip joint prosthesis. The device is designed with a hemispherical shell with an abrasive outer surface as the cutting head that is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy and is available in various sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
895802853
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057968716742MIS 4.0 REAMER HANDLE CUP IMPACTORH00340000992022-09-08
08055727375285DROP HANDLE M8 BLUEH15000002092022-09-05
08055727375322DROP HANDLE CANNULATED M8 VIOLETH15000202192022-09-05
08055727375339DROP HANDLE CANNULATED M8 NIGHT BLUEH15000502192022-09-05
08055727375346DROP HANDLE CANNULATED M8 BLUEH15000002192022-09-05
08055727375353DROP HANDLE CANNULATED M8 BLACKH15000102192022-09-05
08055727375360"T" RATCHED HANDLE YELLOWH15000404092022-09-05
08055727375377"T" RATCHED HANDLE WHITEH15000304092022-09-05
08055727375384"T" RATCHED HANDLE VIOLETH15000204092022-09-05
08055727375391"T" RATCHED HANDLE NIGHT BLUEH15000504092022-09-05
08055727375407"T" RATCHED HANDLE CANNULATED NIGHT BLUEH15000504592022-09-05
08055727375414"T" RATCHED HANDLE CANNULATED YELLOWH15000404592022-09-05
08055727375421"T" RATCHED HANDLE CANNULATED WHITEH15000304592022-09-05
08055727375438"T" RATCHED HANDLE CANNULATED VIOLETH15000204592022-09-05
08055727375445"T" RATCHED HANDLE CANNULATED BLUEH15000004592022-09-05
08055727375452"T" RATCHED HANDLE CANNULATED BLACKH15000104592022-09-05
08055727375469"T" RATCHED HANDLE BLUEH15000004092022-09-05
08055727375476"T" RATCHED HANDLE BLACKH15000104092022-09-05
08055727375483"T" HANDLE M8 YELLOWH15000401592022-09-05
08055727375490"T" HANDLE M8 WHITEH15000301592022-09-05

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