FDA.reportPublic FDA data

Forceps - Rongeur for Cement Extraction (Slide measures 205mm) - 20mm Jaw Width

Primary DI
05056405524103
Brand
Forceps - Rongeur for Cement Extraction (Slide measures 205mm) - 20mm Jaw Width
Company
PLATTS & NISBETT LIMITED
Model
PN2321
Published
2024-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056405524103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056405524103050564055241035056405524103

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement extractor, manualA hand-held manual surgical instrument designed to extract orthopaedic (bone) cement from a site of previous application during an orthopaedic surgical procedure to replace a previously cemented prosthesis. This GMDN code may include slide hammers, chisels, or other manually-operated devices which are intended to be used to break up the bone cement for removal. 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
05056405509179Osteotome - Capener, Straight - 6mm Width with Green Soft Grip HandlePN3113PN31132025-05-21
05056405503986Retractor - JuniperPN05572025-01-21
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091216ELMED INCORPORATEDELMED INCORPORATEDHTX2026-06-03
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00846338005726ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005757ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005764ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005771ForcepsELLIQUENCE, LLCHTX2026-06-02
00846338005788ForcepsELLIQUENCE, LLCHTX2026-06-02
00810189451490Surgical DesignSurgical Design, Inc.HTX2026-05-29
09348811172174INKAThe Trustee for KAISER FAMILY TRUSTHTX2025-11-21
G586NS5235002SPFB10Novo SurgicalNOVO SURGICAL, INC.HTX2025-02-06
G586NS20266610Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS20286510Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS20286810Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G586NS34214310Novo SurgicalNOVO SURGICAL, INC.HTX2024-02-22
G45333CC96MM900PEAK MEDPeak Medical Distribution Inc.HTX2023-03-07
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