AccessGUDID - DEVICE: Silon-TSR 5x5 (00810050460019)

GUDID

Device Identifier (DI) Information

Brand Name: Silon-TSR 5x5
Version or Model: 2025P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2025P
Company Name: Bio Med Sciences, Inc.

Primary DI Number: 00810050460019
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

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:	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?
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: 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
Width: 5 Inch
Length: 5 Inch
Width: 13 Centimeter
Length: 13 Centimeter

Device Record Status

Public Device Record Key: 05481a57-0ed1-4433-8f25-c180dcd4d9f5
Public Version Date: December 25, 2023
Public Version Number: 3
DI Record Publish Date: August 04, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10810050460016	10	00810050460019		In Commercial Distribution	Carton

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(610)530-3193
Email: BioMedCS@silon.com

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