FDA.reportPublic FDA data

Sizer Set - for Use with Osteochondral Allograft, PRE-CUT CORE

Primary DI
00860010346938
Brand
Sizer Set - for Use with Osteochondral Allograft, PRE-CUT CORE
Company
Swami Medical, LLC
Model
PKG-90-AOI-000002
Device description
OCA Single-Use Sizer Set
Published
2024-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QBOInstruments Designed For Press-Fit Osteochondral Implants

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBOInstruments Designed For Press-Fit Osteochondral ImplantsOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010346938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010346938008600103469388600103469380860010346938

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant-instrument extension adaptor, single-useA sterile connecting device designed to join an orthopaedic implant to a surgical instrument, or a surgical instrument to another instrument, typically to create an extension for removal of the implant (e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve), or to connect two devices with incompatible interfaces. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119319166
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010346907Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT COREPKG-90-AOI-0000112024-08-22
00860010346914Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT COREPKG-90-AOI-0000162024-08-22
00860010346921Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT COREPKG-90-AOI-0000202024-08-22

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00840124512863PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
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00840124513884FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQBO2024-09-23
00860010346907Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORESwami Medical, LLCQBO2024-08-22
00860010346914Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORESwami Medical, LLCQBO2024-08-22
00860010346921Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORESwami Medical, LLCQBO2024-08-22
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