FDA.reportPublic FDA data

ACETABULAR REAMER D45 mm HPF

Primary DI
08057968710092
Brand
ACETABULAR REAMER D45 mm HPF
Company
HPF SRL
Model
H0030554599
Published
2022-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
08057968710092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057968710092080579687100928057968710092

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
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
true
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
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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