FDA.report

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
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
QBOInstruments Designed For Press-Fit Osteochondral Implants

Product Code Classifications

CodeDeviceSpecialtyClass
QBOInstruments Designed For Press-Fit Osteochondral ImplantsOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860010346938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010346938008600103469388600103469380860010346938

GMDN Terms

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

Regulatory Flags

DUNS number
119319166
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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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