AccessGUDID - DEVICE: Susol® Blacks File Double Ended Micro with Round Probe 14cm (05060418834029)

GUDID

Device Identifier (DI) Information

Brand Name: Susol® Blacks File Double Ended Micro with Round Probe 14cm
Version or Model: SS08-0557
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BAILEY INSTRUMENTS LTD

Primary DI Number: 05060418834029
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 769260357 *Terms of Use

Device Description: No description.

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):	Yes
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?
65048	Podiatric probe, single-use	A hand-held manual surgical instrument designed for inspection or freeing of the nail bed and nail edges during a podiatric procedure. It is typically made of metal and includes a handle with a fine atraumatic tip. 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: Yes
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: 75b7cbba-8b8b-4e49-84c2-2fb37e4a3a8a
Public Version Date: March 06, 2024
Public Version Number: 1
DI Record Publish Date: February 27, 2024