AccessGUDID - DEVICE: exsalt T7 Wound Dressings (07540127000017)

GUDID

Device Identifier (DI) Information

Brand Name: exsalt T7 Wound Dressings
Version or Model: 09-0103
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T70405
Company Name: Exciton Technologies Inc

Primary DI Number: 07540127000017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 206405370 *Terms of Use

Device Description: Antimicrobial wound dressing, sterile, size 10cm x 12.5cm

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
47042	Wound-nonadherent dressing, absorbent, antimicrobial	A wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113564	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
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 25 Square centimeter

Device Record Status

Public Device Record Key: 97df01bd-f954-45bf-b6aa-aa5d99d14374
Public Version Date: October 05, 2022
Public Version Number: 2
DI Record Publish Date: September 23, 2020