AccessGUDID - DEVICE: Nano fx® (M528550010200)

GUDID

Device Identifier (DI) Information

Brand Name: Nano fx®
Version or Model: 5500-1020
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5500-1020
Company Name: ARTHROSURFACE INCORPORATED

Primary DI Number: M528550010200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 144666109 *Terms of Use

Device Description: NanoFx, Guide, 15 Degree

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?
61412	Subchondral bone needling device handle	A hand-held manual surgical instrument designed as the handle for a subchondral bone needling device used during arthroscopic procedures to create thin channels through the bone layer beneath articular cartilage to enable migration of bone marrow (blood stem) cells to promote healing of a cartilage defect. It is made of plastic materials. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 92aa8e50-3c0a-438e-b046-1681e1e420be
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 20, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 508-520-3003
Email: contact@arthrosurface.com

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