AccessGUDID - DEVICE: Hu-Friedy MFG Co., LLC. (10889950012298)

GUDID

Device Identifier (DI) Information

Brand Name: Hu-Friedy MFG Co., LLC.
Version or Model: FB11/12
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HU-FRIEDY MFG. CO., LLC

Primary DI Number: 10889950012298
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005085972 *Terms of Use

Device Description: #11/12 Buck DE File

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):	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?
35013	Periodontal file/rasp, manual	A hand-held manual dental instrument that has various forms of ridged cutting surfaces at its working end(s) designed to scrape and smooth during a periodontal procedure. It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This device is typically used to remove gross supragingival calculus, smooth the cementoenamel junction (CEJ), and remove overhanging margins of dental restorations. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMR	FILE, PERIODONTIC

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: 9bbc25dc-da58-4f4c-9c2f-3048cc73dc35
Public Version Date: April 17, 2023
Public Version Number: 1
DI Record Publish Date: April 07, 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: No Unit of Use DI Numbers Found 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

[?]

Phone: +1(800)483-7433
Email: info@hu-friedy.com

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

FDA TOOLS & RESOURCES