AccessGUDID - DEVICE: DropSafe™ Inject-Safe Barrier Bandage™ (05907996099979)

GUDID

Device Identifier (DI) Information

Brand Name: DropSafe™ Inject-Safe Barrier Bandage™
Version or Model: n/a
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6070
Company Name: HTL STREFA S A

Primary DI Number: 05907996099979
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 422528088 *Terms of Use

Device Description: Barrier Bandage it’s intended to contain post-injection bleeding during a subcutaneous or intramuscular injection. The device is intended for healthcare professions (HCP) and lay users. The device is an OTC product.

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":	Yes
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?
65285	Skin adhesive protective material	A liquid preparation designed to be applied evenly over intact skin to form a synthetic polymer film, prior to application of an adhesive strip/bandage, to protect the skin during subsequent removal of the adhesive strip/bandage. It may be presented as a wipe/swab. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape And Bandage, Adhesive

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: f25435b0-0849-490a-8ac8-9dd463d4b0b5
Public Version Date: July 03, 2023
Public Version Number: 1
DI Record Publish Date: June 25, 2023