FDA.reportPublic FDA data

AGILON®

Primary DI
04048844620004
Brand
AGILON®
Company
implantcast GmbH
Model
78010156
Device description
box chisel universal
Published
2024-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048844620004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048844620004040488446200044048844620004

GMDN Terms#

Term, Definition table
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 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

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Primary DI, Brand, Company table
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07613327668896Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
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07613327355161REUNIONStryker GmbHHSD2022-11-15
07613327355192REUNIONStryker GmbHHSD2022-11-15
07613327355215REUNIONStryker GmbHHSD2022-11-15
07613327355239REUNIONStryker GmbHHSD2022-11-15
07613327355321REUNIONStryker GmbHHSD2022-11-15
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