FDA.reportPublic FDA data

Osteotome - Capener, Straight - 6mm Width with Green Soft Grip Handle

Primary DI
05056405509179
Brand
Osteotome - Capener, Straight - 6mm Width with Green Soft Grip Handle
Company
PLATTS & NISBETT LIMITED
Model
PN3113
Catalog number
PN3113
Published
2025-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HWMOsteotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056405509179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056405509179050564055091795056405509179

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
290712512
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056405508578Charnley Femoral Prosthesis PusherPN2670PN26702026-02-11
05056405503566Nylon Head Impactor for Femoral Head (spare head for femoral head impactor)PN04752023-09-19
05056405502064Femoral Head Impactor, 204mm O/LPN02832023-09-18
05056405500152Retractor - Travers, CurvedPN0016PN00162025-09-10
05056405520662Sellors KeyPN1831PN18312025-08-27
05056405526398Sellors Retractor Small Blade (Pair)PN2710PN27102025-08-27
05056405526404Sellors Retractor Medium Blade (Pair)PN2711PN27112025-08-27
05056405526411Sellors Retractor Large Blade (Pair)PN2712PN27122025-08-27
05056405527289Sellors - Nut & Bolt (Pair)PN2843PN28432025-08-27
05056405500770Forceps - Lincoln DissectingPN0104PN01042025-07-22
05056405503986Retractor - JuniperPN05572025-01-21
05056405524103Forceps - Rongeur for Cement Extraction (Slide measures 205mm) - 20mm Jaw Width PN23212024-12-16
05056405514135Purse String Forceps, 270mm O/L, 55mm JawPN11992024-12-11
05056405500381Sellors RetractorPN00412024-11-07
05056405501203Murphy Skid Bone LeverPN01652024-10-04
05056405502880Finch Excision Clamp, Hollow Jaw, 235mm O/L, 95mm JawPN03902024-04-15
05056405504235Smith Petersen Osteotome, Curved, 205mm O/L, 13mm Width PN06022024-03-07
05056405508868SPAIRE Hohmann Retractor, Angled, 18mm PN29352023-10-23
05056405508875SPAIRE Iliac Wing RetractorPN29362023-10-23
05056405508882SPAIRE T Handle Retractor with Ischial/Iliac PinsPN29372023-10-23

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