AccessGUDID - DEVICE: Eversense® Insertion Tools Kit (00817491021397)

GUDID

Device Identifier (DI) Information

Brand Name: Eversense® Insertion Tools Kit
Version or Model: FG-8211-01-201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG-8211-01-201
Company Name: SENSEONICS, INCORPORATED

Primary DI Number: 00817491021397
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 966865636 *Terms of Use

Device Description: Eversense Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.

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":	Yes
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?
61914	Subcutaneous implantation kit, non-medicated	A collection of devices intended to be used for the implantation of a subcutaneous device (e.g., implantable glucose sensor) [not included]. It typically consists of a blunt dissector, cannula and may include non-dedicated devices (e.g., dressings); it does not contain pharmaceutical components. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QCD	Continuous Glucose Monitor, Implanted, Adjunctive Use
QHJ	Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160048	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

[?]

Storage and Handling
Storage Environment Temperature: between 50 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f6a52b70-e1cf-4b6f-9cfd-18c5153c4f40
Public Version Date: November 27, 2019
Public Version Number: 3
DI Record Publish Date: July 16, 2018