FDA.reportPublic FDA data

Acetabular reamer ø59mm

Primary DI
07630055302236
Brand
Acetabular reamer ø59mm
Company
Incipio Devices SA
Model
50143959
Catalog number
50143959
Device description
Acetabular reamer for hip arthroplasty
Published
2020-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630055302236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630055302236076300553022367630055302236

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter59Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
485098284
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
07630055306722Offset reamer handle - Dual Coupling90CH.IN.004502445002026-03-17
07630055306739Offset reamer handle - Large AO motor shaft90CH.IN.AO1502445062026-03-17
07630055306746Offset reamer handle - Stryker Z/H motor shaft90CH.IN.ZH1502445072026-03-17
07630055306753Offset reamer handle - Hudson motor shaft90CH.IN.HU1502445082026-03-17
07630055306760Straight reamer handle - large AO - Dual coupling90ST.IN.AO1502445502026-03-17
07630055306777Straight reamer handle -Stryker Z/H - Dual coupling90ST.IN.ZH1502445512026-03-17
07630055306784Straight reamer handle - Hudson - Dual coupling90ST.IN.HU1502445522026-03-17
07630055306791Offset reamer handle - Dual coupling131-174/05502445002026-03-10
07630055306807Offset reamer handle - Handle131-174/01502445042026-03-10
07630055306814Offset reamer handle - Body131-174/02502445052026-03-10
07630055306821Offset reamer handle - Dual Coupling transmission131-174/03502445092026-03-10
07630055306838Offset reamer handle - Large AO motor shaft131-174/04D502445062026-03-10
07630055306845Offset reamer handle - Stryker Z/H motor shaft131-174/04H502445072026-03-10
07630055306852Offset reamer handle - Hudson motor shaft131-174/04B502445082026-03-10
07630055306869Straight reamer handle - Jacobs - Dual coupling131-171E502445492026-03-10
07630055306876Straight reamer handle - large AO - Dual coupling131-171D502445502026-03-10
07630055306883Straight reamer handle -Stryker Z/H - Dual coupling131-171H502445512026-03-10
07630055306890Straight reamer handle - Hudson - Dual coupling131-171B502445522026-03-10
07630055307057Offset reamer handle - Stryker Z/H - Tri coupling2016REAM502445122026-02-04
07630055300102Offset Cup Impactor - M8x1.25 Interface183-151/00183-151/002019-10-04

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