AccessGUDID - DEVICE: SKIN-PREP Wipes (00040565112695)

GUDID

Device Identifier (DI) Information

Brand Name: SKIN-PREP Wipes
Version or Model: 420400, 420471
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 420400, 420471
Company Name: SMITH & NEPHEW MEDICAL LIMITED

Primary DI Number: 00040565112695
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 216344051 *Terms of Use

Device Description: Protective Wipe

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?
58979	Synthetic-polymer liquid barrier dressing, sterile	A sterile 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.	Obsolete	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: eed73a93-0aad-4493-9c10-286a51f9455e
Public Version Date: September 07, 2023
Public Version Number: 2
DI Record Publish Date: December 11, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
00040565114521	50	00040565112695	In Commercial Distribution	Carton 420400
30040565114522	20	00040565114521	In Commercial Distribution	Case 420400
30040565116519	1000	00040565112695	In Commercial Distribution	Case 420471