AccessGUDID - DEVICE: Susol® Partial Nail Avulsion Procedure Pack (05060418834890)

GUDID

Device Identifier (DI) Information

Brand Name: Susol® Partial Nail Avulsion Procedure Pack
Version or Model: BSDP-03
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BAILEY INSTRUMENTS LTD

Primary DI Number: 05060418834890
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?
58940	Podiatry kit, single-use	A collection of devices intended for treatment of cutaneous foot disorders such as hardened skin, corns, and ingrown/ingrowing toenails. It typically consists of two or more of the following items: nail cutters, nail file, dermal curette, scalpel handle and blades, probe, gauze applicators, and/or dressings (e.g., coverings, protection/treatment solutions); it may be used in the home and healthcare facility. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDD	Kit, Surgical Instrument, Disposable

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: 1dbe0bc5-b3fa-46b0-98ea-ed516c54f314
Public Version Date: January 31, 2024
Public Version Number: 1
DI Record Publish Date: January 23, 2024