exsalt T7 Wound Dressing, 4" x 66" T70466

GUDID 07540127000468

antimicrobial wound dressing, 4" x 66" in size

Exciton Technologies Inc

Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial

Primary Device ID	07540127000468
NIH Device Record Key	d55ed2a0-2154-4caf-924b-cf5445c87932
Commercial Distribution Status	In Commercial Distribution
Brand Name	exsalt T7 Wound Dressing, 4" x 66"
Version Model Number	BM-09-0166
Catalog Number	T70466
Company DUNS	206405370
Company Name	Exciton Technologies Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	true
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540127000468 [Primary]
GS1	07540127000475 [Package] Package: Box [4 Units] In Commercial Distribution
GS1	07540127000482 [Package] Contains: 07540127000475 Package: Case [4 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K113564

FDA Product Code

FRO	Dressing, Wound, Drug

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-12-12
Device Publish Date	2023-12-04

Devices Manufactured by Exciton Technologies Inc

07540127000352 - exsalt PT7 Contact Layer; 4" x 5"	2024-03-26 The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, ven
07540127000383 - exsalt PT7 Contact Layer, 6" x 6"	2024-03-26 The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, ven
07540127000413 - exsalt PT7 Contact Layer; 8" x 16"	2024-03-26 The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, ven
07540127000444 - exsalt PT7 Contact Layer; 16" x 16"	2024-03-26 The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, ven
07540127000505 - exsalt PT7 Contact Layer; 16" x 32"	2024-03-26 The exsalt™ PT7 Contact Layer (PT7) is indicated for use on partial and full thickness wounds, including decubitus ulcers, ven
07540127000468 - exsalt T7 Wound Dressing, 4" x 66"	2023-12-12antimicrobial wound dressing, 4" x 66" in size
07540127000468 - exsalt T7 Wound Dressing, 4" x 66"	2023-12-12 antimicrobial wound dressing, 4" x 66" in size
07540127000178 - exsalt CMC Gelling Fiber Dressing	2023-07-18 exsalt™ CMC Gelling Fiber Dressing is a soft, sterile, nonwoven wound dressing made of sodium carboxymethylcellulose (CMC), ce
07540127000208 - exsalt CMC Gelling Fiber Dressing	2023-07-18 exsalt™ CMC Gelling Fiber Dressing is a soft, sterile, nonwoven wound dressing made of sodium carboxymethylcellulose (CMC), ce