AccessGUDID - DEVICE: TenderTrode Plus™ (10813150020579)

GUDID

Device Identifier (DI) Information

Brand Name: TenderTrode Plus™
Version or Model: A10008
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A10008
Company Name: GRAPHIC CONTROLS ACQUISITION CORP

Primary DI Number: 10813150020579
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 002111896 *Terms of Use

Device Description: Thermal Probe Cover 20/pouch, 10 pouches/case, 500 per case

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?
33878	Cable/lead/sensor/probe cover, non-sterile	A non-sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier to protect the contents from soiling and contamination so that the non-sterile contents may be used in the vicinity of, or enter into a hygienic area, e.g., a sterile surgical field. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FMT	Warmer, Infant Radiant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K915831	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: c5051d7b-79a3-421a-9ab3-068d9d9306f5
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: March 02, 2018