FDA.reportPublic FDA data

Theia Negative Pressure Wound Therapy Foam Dressing Kit

Primary DI
00850040200058
Brand
Theia Negative Pressure Wound Therapy Foam Dressing Kit
Company
Clear Choice Therapeutics, Inc.
Model
UN20133M
Published
2022-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211277000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211277000Theia NPWT Foam Wound Dressing KitClear Choice Therapeutics, Inc.2021-12-16OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850040200055PackageGS110In Commercial Distribution
00850040200058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004020005510850040200055
00850040200058008500402000588500402000580850040200058

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system foam dressing, non-antimicrobialA pad made of open-cell foam material designed to be placed into a wound during a vacuum-assisted wound closure procedure, commonly known as negative pressure wound therapy (NPWT); it does not include an antimicrobial agent(s). It is typically used to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. Under NPWT, the open-cell foam dressing decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. It may be cut to conform to the wound. This is a single-use device.

Regulatory Flags#

DUNS number
117673047
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040200010Theia Negative Pressure Wound Therapy Foam Dressing KitFWTS212022-12-23
00850040200027Theia Negative Pressure Wound Therapy Foam Dressing KitFWTM362022-12-23
00850040200034Theia Negative Pressure Wound Therapy Foam Dressing KitFWTL442022-12-23
00850040200041Theia Negative Pressure Wound Therapy Foam Dressing KitUN1083S2022-12-23
00850040200065Theia Negative Pressure Wound Therapy Foam Dressing KitUN25163L2022-12-23

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Primary DI, Brand, Company table
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00849405002819Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002826Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
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00849405002840Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00749756392495DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22
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00849405002703Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
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