AccessGUDID - DEVICE: PEAKOSIL (08800026400134)

GUDID

Device Identifier (DI) Information

Brand Name: PEAKOSIL
Version or Model: NS005P-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEOSIL Co., Ltd

Primary DI Number: 08800026400134
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690409169 *Terms of Use

Device Description: Product Name : Teeth impressions kit This product is a convenience kit including One-time Putty 3EA and 6 dental impression trays. The contents of this kit are all registered in FDA. Its content, One-time Putty is a convenience kit that is changed only in packaging materials from Putty(MSP). These changes don't cause any change in 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?
48085	Dental impression material kit, single-use	A collection of non-sterile devices designed to obtain a negative imprint of the teeth and/or upper palate (i.e., the roof of the mouth with the gums and teeth). It is subsequently used to make a mould for the manufacture of a custom-made dental prosthesis, orthodontic appliance, and/or oral appliance. The kit typically includes dental impression materials and a dental impression tray(s); reusable application devices are not included. Impression material is placed on the tray and the tray is then positioned in the mouth of the patient until the material becomes firm creating the mould. 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: b22f0c3c-0c94-41d7-bf6e-e5df45ee9f98
Public Version Date: January 13, 2020
Public Version Number: 1
DI Record Publish Date: January 03, 2020