FDA.reportPublic FDA data

RAZOR Single-Use Acetabular Reamer

Primary DI
00850022768385
Brand
RAZOR Single-Use Acetabular Reamer
Company
Razor Medical Instruments, Inc.
Model
1001-0064
Catalog number
1001-0064
Device description
Acetabular Orthopedic Reamer, 64mm
Published
2023-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

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
00850022768385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022768385008500227683858500227683850850022768385

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, single-useAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter64Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8003580434qa@razormi.com

Regulatory Flags#

DUNS number
117571863
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
00850022768200RAZOR Single-Use Acetabular Reamer1001-00461001-00462023-11-08
00850022768217RAZOR Single-Use Acetabular Reamer1001-00471001-00472023-11-08
00850022768224RAZOR Single-Use Acetabular Reamer1001-00481001-00482023-11-08
00850022768231RAZOR Single-Use Acetabular Reamer1001-00491001-00492023-11-08
00850022768248RAZOR Single-Use Acetabular Reamer1001-00501001-00502023-11-08
00850022768255RAZOR Single-Use Acetabular Reamer1001-00511001-00512023-11-08
00850022768262RAZOR Single-Use Acetabular Reamer1001-00521001-00522023-11-08
00850022768279RAZOR Single-Use Acetabular Reamer1001-00531001-00532023-11-08
00850022768286RAZOR Single-Use Acetabular Reamer1001-00541001-00542023-11-08
00850022768293RAZOR Single-Use Acetabular Reamer1001-00551001-00552023-11-08
00850022768309RAZOR Single-Use Acetabular Reamer1001-00561001-00562023-11-08
00850022768316RAZOR Single-Use Acetabular Reamer1001-00571001-00572023-11-08
00850022768323RAZOR Single-Use Acetabular Reamer1001-00581001-00582023-11-08
00850022768330RAZOR Single-Use Acetabular Reamer1001-00591001-00592023-11-08
00850022768347RAZOR Single-Use Acetabular Reamer1001-00601001-00602023-11-08
00850022768354RAZOR Single-Use Acetabular Reamer1001-00611001-00612023-11-08
00850022768361RAZOR Single-Use Acetabular Reamer1001-00621001-00622023-11-08
00850022768378RAZOR Single-Use Acetabular Reamer1001-00631001-00632023-11-08
00850022768392RAZOR Single-Use Acetabular Reamer1001-00651001-00652023-11-08
00850022768408RAZOR Single-Use Acetabular Reamer1001-00661001-00662023-11-08

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