AccessGUDID - DEVICE: Seamfree Single Syringe with Tips (00850194007336)

GUDID

Device Identifier (DI) Information

Brand Name: Seamfree Single Syringe with Tips
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 104-01
Company Name: Vista Dental

Primary DI Number: 00850194007336
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 036623932 *Terms of Use

Device Description: Seamfree Single Syringe with Tips

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?
47916	Dental restorative unfilled resin kit, standard	A collection of standard equipment and supplies intended to be used to fill dental cavities or restore damaged dental tissue with unfilled resin, such as polymethylmethacrylate (PMMA), that does not contain or contains very small amounts of inert filler materials. It typically includes dental cannulae (tips), finishing discs, polishing paste, polishing cups, and a tips gun. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, Tooth Shade, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092539	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: 57fb9c0c-f61e-4a3c-8c18-9d5e4d744f83
Public Version Date: February 04, 2021
Public Version Number: 4
DI Record Publish Date: June 16, 2016

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

[?]

No Customer Contact currently defined

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