AccessGUDID - DEVICE: Flex Tab (10841396117319)

GUDID

Device Identifier (DI) Information

Brand Name: Flex Tab
Version or Model: 004-008
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KERR CORPORATION

Primary DI Number: 10841396117319
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 847905890 *Terms of Use

Device Description: Flexible Clearance Tabs (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):	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?
45240	Interproximal/occlusal dental gauge, single-use	A device intended to be used to directly measure the interproximal (adjacent) and/or occlusal (opposing) clearance of a prepared tooth, typically to ensure sufficient space in the development of a dental restoration. The device may be in the form of a flexible tab (e.g., thermoplastic material) available in a variety of standard thicknesses. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFH	PAPER, ARTICULATION

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
Special Storage Condition, Specify: STORE AT AMBIENT TEMPERATURE

Clinically Relevant Size

[?]

Size Type Text
Height: 2 Millimeter

Device Record Status

Public Device Record Key: 53e0ed63-2618-4076-afdd-aa1aff81689b
Public Version Date: August 09, 2019
Public Version Number: 3
DI Record Publish Date: August 31, 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: 00841396117312 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: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +18005377123
Email: customercare@kavokerrgroup.com

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