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

GUDID

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

Primary DI Number: 04260451444013
Issuing Agency: GS1
Device Count: 5

Device Description: Disposable Extension Cable

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 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.

Product Code	Product Code Name
IKD	CABLE, ELECTRODE

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

Sterilization Method [?]
Ethylene Oxide

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

Size Type Text
Length: 250 Centimeter

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 08, 2016
Commercial Distribution End Date:

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

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

Unit of Use DI Number: 04260451444020 CLOSE

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

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

Phone: +1(727)937-2511
Email: sales@oscor.com