AccessGUDID - DEVICE: MaXcess (00887517198686)

GUDID

Device Identifier (DI) Information

Brand Name: MaXcess
Version or Model: 3243160
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nuvasive, Inc.

Primary DI Number: 00887517198686
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053950783 *Terms of Use

Device Description: MaXcess 4 Blade, 160mm Electrode Ctr

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:	No
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Surgical retractor/retraction system blade, reusable	A component of a surgical retraction system or surgical retractor designed to function as a parting edge to separate the margins of a wound/incision during an open surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle because it is available in a variety of lengths and sizes. It is made of high-grade stainless steel. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Surgical retractor/retraction system blade, reusable

A component of a surgical retraction system or surgical retractor designed to function as a parting edge to separate the margins of a wound/incision during an open surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle because it is available in a variety of lengths and sizes. It is made of high-grade stainless steel. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
ETN	STIMULATOR, NERVE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112709	000

Device Exempt from Premarket Submission: No 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: add7920e-16de-4c0e-ba10-19d78234c2f7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 13, 2016