AccessGUDID - DEVICE: SCOTT'S SELECT BARBED BROACHES 10/pk 21mm # MEDIUM (D77811271301)

GUDID

Device Identifier (DI) Information

Brand Name: SCOTT'S SELECT BARBED BROACHES 10/pk 21mm # MEDIUM
Version or Model: 112-7130
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 112-7130
Company Name: SCOTT'S DENTAL SUPPLY L.L.C.

Primary DI Number: D77811271301
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 137217043 *Terms of Use

Device Description: BARBED BROACHES (10/pack) Length: 21mm, Size: Medium, Material: Stainless Steel, Color: Green; For more information: https://www.scottsdental.com/catalog/product/view/id/24126/s/barbed-broaches-scott-s-select/

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?
63694	Sonic endodontic broach	A non-sterile dental endpiece designed to be attached to a sonic dental handpiece for the application of sonic vibrations to shape and enlarge holes in root canal tissue, particularly dentine, or for extirpating pulp. It is a tapered and serrated/barbed thin rod made of metal. 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: 5fea5d98-c686-44a1-a631-db9cbf442f46
Public Version Date: March 08, 2021
Public Version Number: 1
DI Record Publish Date: February 27, 2021