FDA.reportPublic FDA data

ACS®

Primary DI
04048844042561
Brand
ACS®
Company
implantcast GmbH
Model
42220005
Device description
patella drill guide 32/35mm
Published
2024-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048844042561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048844042561040488440425614048844042561

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
324369826
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048844007966n/a028200022026-05-06
04048844017293NA258628002026-05-06
04048844017316NA258628102026-05-06
04048844111250NA258640002026-05-06
04048844111267NA258640052026-05-06
04048844111274NA258640102026-05-06
04048844111281NA258640152026-05-06
04048844150228n/a028200402026-05-06
04048844708344EPORE® XO022080422026-05-06
04048844708375EPORE® XO022080442026-05-06
04048844708405EPORE® XO022080462026-05-06
04048844708429EPORE® XO022080482026-05-06
04048844708450EPORE® XO022080522026-05-06
04048844708467EPORE® XO022080542026-05-06
04048844711566EPORE® XO022080562026-05-06
04048844711573EPORE® XO022080582026-05-06
04048844711580EPORE® XO022080602026-05-06
04048844711603EPORE® XO022080642026-05-06
04048844711610EPORE® XO022080662026-05-06
04048844711627EPORE® XO022080682026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001257SurgiCase PlannerMaterialise NVJWH2026-05-28
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07613327000092INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000108INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
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07613327010121INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327013511TriathlonHowmedica Osteonics Corp.JWH2015-09-24
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07613327013542TriathlonHowmedica Osteonics Corp.JWH2015-09-24
07613327013559TriathlonHowmedica Osteonics Corp.JWH2015-09-24
07613327013573TriathlonHowmedica Osteonics Corp.JWH2015-09-24