FDA.reportPublic FDA data

"exsalt T7 Wound Dressing, 4"" x 66"""

Primary DI
07540127000468
Brand
"exsalt T7 Wound Dressing, 4"" x 66"""
Company
Exciton Technologies Inc
Model
BM-09-0166
Catalog number
T70466
Device description
"antimicrobial wound dressing, 4"" x 66"" in size"
Published
2023-12-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113564000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113564000EXSALT T7 WOUND DRESSINGExciton Technologies, Inc.2011-12-15FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540127000475PackageGS14In Commercial Distribution
07540127000482PackageGS14In Commercial Distribution
07540127000468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540127000475075401270004757540127000475
07540127000482075401270004827540127000482
07540127000468075401270004687540127000468

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, antimicrobialA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
206405370
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540127000406exsalt PT7 Contact Layer; 8" x 16"PN-09-0064CL08162024-03-18
07540127000437"exsalt PT7 Contact Layer; 16"" x 16"""PN-09-0065CL16162024-03-18
07540127000529"exsalt PT7 Contact Layer, 4"" x 66"""PN-09-0130CL04662025-07-04
07540127000345"exsalt PT7 Contact Layer; 4"" x 5"""PN-09-0062CL04052024-03-18
07540127000376"exsalt PT7 Contact Layer, 6"" x 6"""PN-09-0063CL06062024-03-18
07540127000499"exsalt PT7 Contact Layer; 16"" x 32"""PN-09-0066CL16322024-03-18
07540127000352exsalt PT7 Contact Layer; 4" x 5"PN-09-0062CL04052024-03-18
07540127000383exsalt PT7 Contact Layer, 6" x 6"PN-09-0063CL06062024-03-18
07540127000413exsalt PT7 Contact Layer; 8" x 16"PN-09-0064CL08162024-03-18
07540127000444exsalt PT7 Contact Layer; 16" x 16"PN-09-0065CL16162024-03-18
07540127000505exsalt PT7 Contact Layer; 16" x 32"PN-09-0066CL16322024-03-18
07540127000161exsalt CMC Gelling Fiber DressingPN-09-0121GF02022023-07-10
07540127000192exsalt CMC Gelling Fiber DressingPN-09-0122GF04052023-07-10
07540127000222exsalt CMC Gelling Fiber DressingPN-09-0123GF06062023-07-10
07540127000253exsalt CMC Gelling Fiber DressingPN-09-0124GF08122023-07-10
07540127000284exsalt CMC Gelling Fiber DressingPN-09-0125GF01122023-07-10
07540127000314exsalt CMC Gelling Fiber DressingPN-09-0126GF01182023-07-10
07540127000178exsalt CMC Gelling Fiber DressingPN-09-0121GF02022023-07-10
07540127000208exsalt CMC Gelling Fiber DressingPN-09-0122GF04052023-07-10
07540127000239exsalt CMC Gelling Fiber DressingPN-09-0123GF06062023-07-10

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