AccessGUDID - DEVICE: 34mm x 28mm x 12° ALIF Rasp Kit 11, 13, 15, 17mm Heights (B064XM34113571)

GUDID

Device Identifier (DI) Information

Brand Name: 34mm x 28mm x 12° ALIF Rasp Kit 11, 13, 15, 17mm Heights
Version or Model: XM-341-1357
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: XENCO MEDICAL LLC

Primary DI Number: B064XM34113571
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079282130 *Terms of Use

Device Description: No description.

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:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Orthopaedic implant/trial-implant holder, single-use	A sterile hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant or trial implant to facilitate guidance, gauging, and monitoring of the implant or trial implant during the orthopaedic procedure. The instrument is typically made of high-grade stainless steel or synthetic materials and is typically constructed in the form of a long shaft with a handle at the proximal end and an implant holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Orthopaedic implant/trial-implant holder, single-use

A sterile hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant or trial implant to facilitate guidance, gauging, and monitoring of the implant or trial implant during the orthopaedic procedure. The instrument is typically made of high-grade stainless steel or synthetic materials and is typically constructed in the form of a long shaft with a handle at the proximal end and an implant holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation 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: a38d62fc-d049-4e89-8c21-7934ec6a1810
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 28, 2015