AccessGUDID - DEVICE: Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORE (00860010346921)

GUDID

Device Identifier (DI) Information

Brand Name: Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORE
Version or Model: PKG-90-AOI-000020
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Swami Medical, LLC

Primary DI Number: 00860010346921
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119319166 *Terms of Use

Device Description: OCA Single-Use Instrumentation Set, 20mm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56640	Orthopaedic implant-instrument extension adaptor, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QBO	Instruments Designed For Press-Fit Osteochondral Implants

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 97aa3bbb-d8ec-4a05-8595-23fb0e1a6fbf
Public Version Date: August 30, 2024
Public Version Number: 1
DI Record Publish Date: August 22, 2024