AccessGUDID - DEVICE: PEAKOSIL (08800026400127)

GUDID

Device Identifier (DI) Information

Brand Name: PEAKOSIL
Version or Model: NS005P-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEOSIL Co., Ltd

Primary DI Number: 08800026400127
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690409169 *Terms of Use

Device Description: Product Name: PEAKOSIL One-Time Putty This product is a convenience kit of Putty(MSP). This product changed only in packaging materials from Putty. These changes don't cause any change from the original functions of Putty. Importer as Retailer is exempt from FDA’S medical device, Establishment Registration, under 21 CFR, 807.65 (e) and (i).

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
35866	Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELW	Material, Impression

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152180	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: 4117644e-223b-4bd7-9e40-cd6ebfaa441f
Public Version Date: June 30, 2021
Public Version Number: 4
DI Record Publish Date: January 03, 2020