AccessGUDID - DEVICE: HU-FRIEDY (10889950097783)

GUDID

Device Identifier (DI) Information

Brand Name: HU-FRIEDY
Version or Model: SP6665
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SP6665
Company Name: HU-FRIEDY MFG. CO., LLC

Primary DI Number: 10889950097783
Issuing Agency: GS1
Commercial Distribution End Date: April 09, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 005085972 *Terms of Use

Device Description: SP6061/CSA6 DE Spatula, #6 Handle

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?
35697	Dental material application tool, single-use	A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

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: d80b2f6f-7312-4a10-8590-a253167eb3cc
Public Version Date: October 22, 2024
Public Version Number: 2
DI Record Publish Date: November 12, 2020