AccessGUDID - DEVICE: SNAP™ (00810000528233)

GUDID

Device Identifier (DI) Information

Brand Name: SNAP™
Version or Model: S424-R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S424-R
Company Name: PARKELL, INC.

Primary DI Number: 00810000528233
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 009900424 *Terms of Use

Device Description: SNAP™ Intro Kit (1-Liquid & 4-Powders) with Russian Labeling (Kraftway)

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:	No
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?
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBG	Crown And Bridge, Temporary, Resin

FDA Premarket Submission

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

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
Storage Environment Temperature: between 7 and 24 Degrees Celsius
Special Storage Condition, Specify: Store this products tightly sealed, away from extreme cold, direct light or high heat. Do not store near eugenol containing materials.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d7c05c97-b1a8-4def-8321-cb0c2523ca99
Public Version Date: October 29, 2021
Public Version Number: 2
DI Record Publish Date: June 11, 2021

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: No Unit of Use DI Numbers Found 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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 6312491134
Email: customerservice@parkell.com

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