AccessGUDID - DEVICE: iSmile (00816419021631)

GUDID

Device Identifier (DI) Information

Brand Name: iSmile
Version or Model: 25-5002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 25-5002
Company Name: Ismile Dental Products, Inc.

Primary DI Number: 00816419021631
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1000
Labeler D-U-N-S® Number*: 016765988 *Terms of Use

Device Description: Tray Cover Size B 8-1/2" x 12-1/4" Blue

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:	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?
64367	Instrument tray cover, single-use	A flexible, synthetic polymer cover designed to be placed on an instrument tray to provide a protective barrier for the transport and short-term storage of clinical instruments (typically endoscopes or surgical instruments). It is typically available in two colours to indicate clean/sterile or contaminated; a tray liner is typically supplied with the device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRU	Chair, Dental, Without Operative Unit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 13eee9d1-6bd2-4fcf-a1bb-28d234218f4c
Public Version Date: June 29, 2023
Public Version Number: 1
DI Record Publish Date: June 21, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

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

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 20816419021635 CLOSE

Direct Marking (DM)

[?]

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

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

Phone: 916-928-0359
Email: info@ismiledp.com

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