AccessGUDID - DEVICE: exsalt PT7 Contact Layer, 4" x 66" (07540127000529)

GUDID

Device Identifier (DI) Information

Brand Name: exsalt PT7 Contact Layer, 4" x 66"
Version or Model: PN-09-0130
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CL0466
Company Name: Exciton Technologies Inc

Primary DI Number: 07540127000529
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 206405370 *Terms of Use

Device Description: The exsalt PT7 Contact Layer contains silver that inhibits bacterial growth in the dressing, as shown in-vitro for up to 7 days against Staphylococcus aureus, Enterococcus faecalis, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, and Acinetobacter baumanii. The exsalt PT7 Contact Layer consists of three layers: Two non adherent polyethylene mesh wound contact layers and an absorbent core made of polyester; all three layers are silver coated. The concentration of silver on the exsalt PT7 Contact Layer is approximately 0.4 mg/cm2 (4.5% w/w). The exsalt PT7 Contact layer meets pyrogen limit specifications. The exsalt PT7 Contact Layer is indicated for use in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts, and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.

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":	Yes
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 [?]
K182680	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: 1680 Square centimeter

Device Record Status

Public Device Record Key: 2fecc6f4-2cd5-4aaa-982c-71555b2669ab
Public Version Date: July 14, 2025
Public Version Number: 1
DI Record Publish Date: July 04, 2025