AccessGUDID - DEVICE: Premier Barbed Broaches (D6919053631)

GUDID

Device Identifier (DI) Information

Brand Name: Premier Barbed Broaches
Version or Model: 9053631
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PREMIER DENTAL PRODUCTS COMPANY

Primary DI Number: D6919053631
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 014789663 *Terms of Use

Device Description: BROACH BARBD 25 PH BX 144

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?
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

FDA Product Code

[?]

Product Code	Product Code Name
EKW	Broach, Endodontic

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 9fc0a15d-c8d4-447d-8359-5cf466c3a142
Public Version Date: October 25, 2023
Public Version Number: 1
DI Record Publish Date: October 17, 2023