AccessGUDID - DEVICE: Interproximal Abrasive Contact (D248138701)

GUDID

Device Identifier (DI) Information

Brand Name: Interproximal Abrasive Contact
Version or Model: 13870
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HAGER WORLDWIDE, INC.

Primary DI Number: D248138701
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 8
Labeler D-U-N-S® Number*: 009277971 *Terms of Use

Device Description: Double-sided, abrasive

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?
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
EHJ	DISK, ABRASIVE

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: 577e432a-370a-48c0-a735-9b8de8d526ad
Public Version Date: July 21, 2023
Public Version Number: 1
DI Record Publish Date: July 13, 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: D248138700 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: +1(828)624-3319
Email: d.pritchard@hagerworldwide.com

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