AccessGUDID - DEVICE: Surgical Direct (B382SD99238561000)

GUDID

Device Identifier (DI) Information

Brand Name: Surgical Direct
Version or Model: SD9923856100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SD9923856100
Company Name: Surgical Direct, Inc.

Primary DI Number: B382SD99238561000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124367223 *Terms of Use

Device Description: Schluger Periodontal File, Fig. 9/10

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?
11703	Callous file/rasp, reusable	A hand-held manual instrument with a surface(s) of coarse and/or fine grooves or teeth at the distal working end designed to be rubbed back and forth over the skin to remove callouses (i.e., hardened and thickened protrusions of skin commonly known as hard skin). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIX	Probe, 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: 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: 830b451c-dc15-4b52-8310-835e18080551
Public Version Date: April 17, 2024
Public Version Number: 2
DI Record Publish Date: July 21, 2023