AccessGUDID - DEVICE: Silon-TSR Face Mask Kit (00810050460057)

GUDID

Device Identifier (DI) Information

Brand Name: Silon-TSR Face Mask Kit
Version or Model: 2200P-K
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2200P-K
Company Name: Bio Med Sciences, Inc.

Primary DI Number: 00810050460057
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 364435974 *Terms of Use

Device Description: Perforated Temporary Skin Replacement Face Mask, Spandage® Tubular Net Dressing, Mastisol® Liquid Adhesion Promoter and5 pks. (2) Sterile 4” x 4” Absorbent Gauze Pads

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
58316	Synthetic polymer semi-permeable film dressing, wound-nonadherent	A sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed. It may be applied directly to tissue or used in combination with other dressings (e.g., gels) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, shallow ulcers). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MGP	Dressing, Wound And Burn, Occlusive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K923150	000

Device Exempt from Premarket Submission: No 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: 526e9d13-a9e6-4c6e-8d13-22ae66c6fd1b
Public Version Date: December 25, 2023
Public Version Number: 3
DI Record Publish Date: August 04, 2023