AccessGUDID - DEVICE: SCOTT'S SELECT BARBED BROACHES 10/pk 21mm # XXXXF (D77811271201)

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Device Identifier (DI) Information

Brand Name: SCOTT'S SELECT BARBED BROACHES 10/pk 21mm # XXXXF
Version or Model: 112-7120
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 112-7120
Company Name: SCOTT'S DENTAL SUPPLY L.L.C.

Primary DI Number: D77811271201
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: XXXX-Fine, Material: Stainless Steel, Color: Purple; For more information: https://www.scottsdental.com/catalog/product/view/id/24126/s/barbed-broaches-scott-s-select/

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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, 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?
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

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FDA Product Code

Product Code	Product Code Name
EKW	BROACH, ENDODONTIC

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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

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Storage and Handling

Storage and Handling
No storage/handling found

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Clinically Relevant Size

Size Type Text
No Device Sizes

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Device Record Status

Public Device Record Key: 75cbbf6e-4820-4e87-8426-3aceca6e2436
Public Version Date: March 08, 2021
Public Version Number: 1
DI Record Publish Date: February 27, 2021

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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

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Secondary DI

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

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Unit of Use DI

Unit of Use DI Number: D77811271200 CLOSE

Direct Marking (DM)

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
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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(800)901-3368
Email: info@scottsdental.com

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