FDA.report

ACS®

Primary DI
04048844464684
Brand
ACS®
Company
implantcast GmbH
Model
42102230
Device description
PS box chisel +1mm
Published
2024-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications

CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048844464684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048844464684040488444646844048844464684

GMDN Terms

TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. 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, flat or curved [(concave) - also known as a hollow blade] in design. 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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
324369826
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04048844358617MUTARS®770300852026-03-24
04048844358716MUTARS®770301052026-03-24
04048844358792MUTARS®770301252026-03-24
04048844358839MUTARS®770301352026-03-24
04048844732103n/a800930002026-03-24
04048844738150implaFit®800820252026-03-24
04048844731977implaFit®800920002026-03-20
04048844731984implaFit®800920012026-03-20
04048844731991implaFit®800920022026-03-20
04048844732004implaFit®800920032026-03-20
04048844732028implaFit®800920062026-03-20
04048844732042implaFit®800920072026-03-20
04048844732059implaFit®800920082026-03-20
04048844732066implaFit®800920092026-03-20
04048844732080implaFit®800920112026-03-20
04048844732097implaFit®800920122026-03-20
04048844781101implaFit®800920052026-03-20
04048844693350implaFit®800900002026-03-17
04048844693374implaFit®800900022026-03-17
04048844693381implaFit®800900032026-03-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00889024706774Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00889024706781Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00889024706798Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00889024706804Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00889024706811Biomet®Biomet Orthopedics, LLCJWH2026-03-12
00843575127143MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127150MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127167MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127174MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127181MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127198MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127204MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127211MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127228MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127235MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127242MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127259MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127266MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127273MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127280MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127297MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127303MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127310MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127327MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127334MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127341MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127358MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127365MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127372MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06
00843575127389MOBIO™ Total Knee SystemB-ONE ORTHO, CORP.JWH2026-03-06