AccessGUDID - DEVICE: Dental City (D771391785)

Skip to Main Content

GUDID

View all sections | Close all sections

Device Identifier (DI) Information

Brand Name: Dental City
Version or Model: 39-1785
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ICP, INC.

Primary DI Number: D771391785
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 808371371 *Terms of Use

Device Description: Barbed Broaches XXXX-Fine 10/Pack Purple

CLOSE

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):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63202	Endodontic broach, serrated, single-use	A hand-held, manual, dental, cutting instrument with a slender, tapered, serrated/barbed tip intended to be used for shaping and enlarging holes in root canal tissue, particularly dentine, or for extirpating pulp. This is a single-use device.	Active	false

CLOSE

FDA Product Code

Product Code	Product Code Name
EKW	Broach, Endodontic

CLOSE

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

CLOSE

Storage and Handling

Storage and Handling
No storage/handling found

CLOSE

Clinically Relevant Size

Size Type Text
No Device Sizes

CLOSE

Device Record Status

Public Device Record Key: 9425a4d6-aa83-4252-beee-2e813711434d
Public Version Date: July 23, 2021
Public Version Number: 1
DI Record Publish Date: July 15, 2021

CLOSE

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

CLOSE

Secondary DI

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

CLOSE

Unit of Use DI

Unit of Use DI Number: D7713917850 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

No Customer Contact currently defined

CLOSE

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES