AccessGUDID - DEVICE: SECURA No-Sting Barrier Film Wipes Bulk (05000223469542)

GUDID

Device Identifier (DI) Information

Brand Name: SECURA No-Sting Barrier Film Wipes Bulk
Version or Model: 02676
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 02676
Company Name: SMITH & NEPHEW MEDICAL LIMITED

Primary DI Number: 05000223469542
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 216344051 *Terms of Use

Device Description: No-Sting Barrier Film

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):	Yes
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?
58978	Synthetic-polymer liquid barrier dressing	A liquid preparation composed of synthetic polymer materials intended to form a thin protective film when applied to superficial wounds (e.g., minor cuts, abrasions) and/or intact skin (typically sensitive areas such as around a stoma), to reduce exposure to external contaminants; may also be intended to augment the adherence of medical adhesives, or provide a protective interface when removing medical adhesives. It may be presented as a wipe, swab, or spray. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEC	Bandage, Liquid, Skin Protectant

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: 2d1ca285-d1fc-48c8-bfab-1755407e9b3e
Public Version Date: January 29, 2024
Public Version Number: 3
DI Record Publish Date: September 04, 2020