AccessGUDID - DEVICE: XI.D-RL™ (04260451444013)

GUDID

Device Identifier (DI) Information

Brand Name: XI.D-RL™
Version or Model: XI.D-RL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XI.D-RL
Company Name: Oscor Inc.

Primary DI Number: 04260451444013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 101835833 *Terms of Use

Device Description: Disposable Extension Cable

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

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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
Pacing/defibrillation lead electrical adaptor	A sterile implantable device designed to adapt the electrical connectors of an implanted pacemaker and/or defibrillator pacing lead to a non-compatible pacemaker or defibrillator (i.e., when they do not meet connection design). This device is implanted with the pacemaker or defibrillator system.

FDA Product Code

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Product Code	Product Code Name
IKD	CABLE, ELECTRODE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070926	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

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Storage and Handling
Storage Environment Temperature: between 5 and 30 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Length: 250 Centimeter

Device Record Status

Public Device Record Key: 9b204bca-af35-4ac2-8c69-8afcd1bf566e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 26, 2017