AccessGUDID - DEVICE: Securi-T (00610075069514)

GUDID

Device Identifier (DI) Information

Brand Name: Securi-T
Version or Model: 7200444
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7200444
Company Name: HOLLISTER INCORPORATED

Primary DI Number: 00610075069514
Issuing Agency: GS1
Commercial Distribution End Date: May 30, 2025
Device Count: 10
Labeler D-U-N-S® Number*: 005527098 *Terms of Use

Device Description: Hydrocolloid Skin Barrier

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?
46207	Peristomal/periwound dressing	A non-sterile substance or material intended to be applied to peristomal and/or periwound skin intended to protect it from body effluent (e.g., faeces, urine, wound exudate) and/or to help secure the seal of a stomal appliance or wound dressing. The device is typically available in a variety of forms including cream, paste in a tube or other applicator, paste in ready formed strips, or powder. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EXE	PROTECTOR, OSTOMY

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: 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
Height: 10 Centimeter
Width: 10 Centimeter

Device Record Status

Public Device Record Key: 83c291f4-55ec-468a-ad9e-85e3ee79b94f
Public Version Date: June 03, 2025
Public Version Number: 2
DI Record Publish Date: December 01, 2022