AccessGUDID - DEVICE: ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY (B278AMMS070MF0)

GUDID

Device Identifier (DI) Information

Brand Name: ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY
Version or Model: AM-MS-070MF
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ONKOS SURGICAL, INC.

Primary DI Number: B278AMMS070MF0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080254074 *Terms of Use

Device Description: ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY ANTIBACTERIAL COATED MALE-FEMALE MIDSECTION SIZE 70MM

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):	Yes
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?
61562	Body femoral/tibial extension stem, coated	A sterile implantable device intended to provide an extension of, or coupling with, other components of a modular femoral/tibial prosthesis in the medullary canal to compensate for bone loss during revision arthroplasty or bone resection. The device is a solid/dense body made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QZZ	Limb And Joint Salvage Device With Coating For Bacteria Reduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN210058	000

Device Exempt from Premarket Submission: No 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
Length: 70 Millimeter

Device Record Status

Public Device Record Key: 8f76b7f0-2f25-4e57-a634-4d07a85257e9
Public Version Date: December 24, 2024
Public Version Number: 2
DI Record Publish Date: December 13, 2024