FDA.reportPublic FDA data

Radial Osteotome, 12mm X 5”

Primary DI
00847538008678
Brand
Radial Osteotome, 12mm X 5”
Company
SYMMETRY MEDICAL INC.
Model
11-020-500
Catalog number
2709-04-013;47-9986-020-29
Device description
Radial Osteotome, 12mm X 5”
Published
2022-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GFIOsteotome, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847538008678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847538008678008475380086788475380086780847538008678

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079881212
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847538005479Patella Caliper802-01-1122025-12-10
00847538009415Short Fin Osteotome Blade11-136-5012500-10-7562024-06-28
00847538008654HP Extraction Standard Removal Case87-10082011-03-0482023-11-28
00847538009330Long Radial Osteotome Blade11-127-5032500-10-7552023-10-23
00847538009293Short Radial Osteotome Blade11-127-5012500-10-7532023-09-22
00847538009316Medium Radial Osteotome Blade11-127-5022500-10-7542023-09-22
00847538009354Long Flat Osteotome Blade11-130-5012500-10-7522023-09-22
00847538009378Medium Flat Osteotome Blade11-130-5022500-10-7512023-09-22
00847538018721GLOBAL UNITE™ Short Stem Instrumentation2128118002021-09-01
00847538018738GLOBAL UNITE™ Short Stem Instrumentation2128111002021-09-01
00847538018745GLOBAL UNITE™ Short Stem Instrumentation2128111202021-09-01
00847538018769GLOBAL UNITE™ Short Stem Instrumentation2128111402021-09-01
00847538018776GLOBAL UNITE™ Short Stem Instrumentation2128111602021-09-01
00847538015256Flexible Osteotome System with Radel Case30-005-0002709-04-000; 30-005-000-15002023-07-17
00847538019179Femoral Tray30-037-4002709-01-000; 30-037-400-15002023-07-17
00817766026423GLOBAL UNITE™ Short Stem Instrumentation2236002112021-09-01
00847538004236Adapter Shaft AO Small To Hudson09-159-0002810010302022-07-22
00847538001006Flag Splitter10-001-00000-9986-010-12;4300012022-05-12
00847538018868Cutting Pliers74-388-0002312201142022-07-12
00847538018882Large Fragment Bone Clamp74-294-0008162990112022-07-12

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