FDA.reportPublic FDA data

RAZOR Femoral Head Trial

Primary DI
00850022768194
Brand
RAZOR Femoral Head Trial
Company
Razor Medical Instruments, Inc.
Model
1105-0036-P
Catalog number
1105-0036-P
Device description
36mm Femoral Head Trials
Published
2023-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022768194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022768194008500227681948500227681940850022768194

GMDN Terms#

Term, Definition table
TermDefinition
Femoral head prosthesis trialA copy of a final femoral head prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size, and to help achieve the desired offset, leg-length, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral stem trial or final prostheses; some may be used with explantation instruments during removal of implanted acetabulum cups. It is typically made of metal or polymer material and includes trial adapters used with large trial heads. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter36Millimeter

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
8003580434qa@razormi.com

Regulatory Flags#

DUNS number
117571863
Device count
1
Premarket exempt
true
Sterilization required before use
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
00850022768385RAZOR Single-Use Acetabular Reamer1001-00641001-00642023-11-08
00850022768392RAZOR Single-Use Acetabular Reamer1001-00651001-00652023-11-08

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