FDA.reportPublic FDA data

Suprasorb P Sensitive Ag

Primary DI
04063591428147
Brand
Suprasorb P Sensitive Ag
Company
L&R USA INC.
Model
12.5cm x 12.5cm with border
Catalog number
180012
Published
2021-09-15
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
FRODressing, Wound, Drug

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170077000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170077000LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd.2017-03-30FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04063591428154PackageGS110In Commercial Distribution
04063591428161PackageGS11In Commercial Distribution
04063591428178PackageGS120In Commercial Distribution
04063591428147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04063591428154040635914281544063591428154
04063591428161040635914281614063591428161
04063591428178040635914281784063591428178
04063591428147040635914281474063591428147

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.

Regulatory Flags#

DUNS number
849081406
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06940610121600Suprasorb P Heel13cm x 10cm non-adhesive1800402023-07-06
06940610121617Suprasorb P Heel13cm x 10cm non-adhesive1800402023-07-06
04063591522579Suprasorb P Heel13cm x 10cm non-adhesive1800402023-02-09
04063591522531Suprasorb P Heel13cm x 10cm non-adhesive1800402023-02-09
10744084000675Suprasorb A+Ag10cm x 20cm327582021-09-17
10744084000644Suprasorb A+Ag5cm x 5cm327552021-09-17
20744084000641Suprasorb A+Ag5cm x 5cm327552021-09-17
20744084000672Suprasorb A+Ag10cm x 20cm327582021-09-17
04063591428024Suprasorb P Sensitive Ag10cm x 10cm with border1800112021-09-15
04063591428062Suprasorb P Sensitive Ag15cm x 15cm with border1800132021-09-15
04063591428109Suprasorb P Sensitive Ag20cm x 20cm with border1800142021-09-15
04063591428185Suprasorb P Sensitive Ag5cm x 5cm no border1800152021-09-15
04063591428222Suprasorb P Sensitive Ag10cm x 10cm no border1800162021-09-15
04063591428260Suprasorb P Sensitive Ag10cm x 12.5cm no border1800172021-09-15
04063591428307Suprasorb P Sensitive Ag15cm x 15cm no border1800182021-09-15
04063591428345Suprasorb P Sensitive Ag20cm x 20cm no border1800192021-09-15
04063591426150Suprasorb P Sensitive Ag7.5cm x 7.5cm with border1800102021-09-15
04063591428031Suprasorb P Sensitive Ag10cm x 10cm with border1800112021-09-15
04063591428079Suprasorb P Sensitive Ag15cm x 15cm with border1800132021-09-15
04063591428116Suprasorb P Sensitive Ag20cm x 20cm with border1800142021-09-15

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Primary DI, Brand, Company table
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09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
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09120073781567GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
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10197344169412MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
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10197344169467MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
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10197344170197MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-10-13
10192253046274KendallCardinal Health 200, LLCFRO2025-09-22
10192253047837XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047844XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047851XeroformCardinal Health 200, LLCFRO2025-09-22