FDA.reportPublic FDA data

46mm Single-Use Acetabular Reamer

Primary DI
00850032869003
Brand
46mm Single-Use Acetabular Reamer
Company
Osteofit LLC
Model
11-100-0046
Catalog number
11-100-0046
Published
2022-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
00850032869003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032869003008500328690038500328690030850032869003

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, single-useAn orthopaedic surgical instrument designed to resect bone (cut out part of the bone) and precisely shape a specific area of bone as it is advanced for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy available in varying sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
020886963
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0085003286907251mm Single-Use Acetabular Reamer11-100-005111-100-00512023-12-06
0085003286908953mm Single-Use Acetabular Reamer11-100-005311-100-00532023-12-06
0085003286909655mm Single-Use Acetabular Reamer11-100-005511-100-00552023-12-06
0085003286910257mm Single-Use Acetabular Reamer11-100-005711-100-00572023-12-06
0085003286911945mm Single-Use Acetabular Reamer11-100-004511-100-00452023-12-06
0085003286912647mm Single-Use Acetabular Reamer11-100-004711-100-00472023-12-06
0085003286913349mm Single-Use Acetabular Reamer11-100-004911-100-00492023-12-06
0085003286901048mm Single-Use Acetabular Reamer11-100-004811-100-00482022-08-04
0085003286902750mm Single-Use Acetabular Reamer11-100-005011-100-00502022-08-04
0085003286903452mm Single-Use Acetabular Reamer11-100-005211-100-00522022-08-04
0085003286904154mm Single-Use Acetabular Reamer11-100-005411-100-00542022-08-04
0085003286905856mm Single-Use Acetabular Reamer11-100-005611-100-00562022-08-04
0085003286906558mm Single-Use Acetabular Reamer11-100-005811-100-00582022-08-04

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