FDA.reportPublic FDA data

Suprasorb P Sensitive Ag

Primary DI
04063591428079
Brand
Suprasorb P Sensitive Ag
Company
L&R USA INC.
Model
15cm x 15cm with border
Catalog number
180013
Published
2021-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
04063591428079PackageGS110In Commercial Distribution
04063591428086PackageGS11In Commercial Distribution
04063591428093PackageGS120In Commercial Distribution
04063591428062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04063591428079040635914280794063591428079
04063591428086040635914280864063591428086
04063591428093040635914280934063591428093
04063591428062040635914280624063591428062

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
849081406
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
04063591428147Suprasorb P Sensitive Ag12.5cm x 12.5cm with border1800122021-09-15
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
04063591428116Suprasorb P Sensitive Ag20cm x 20cm with border1800142021-09-15

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Primary DI, Brand, Company table
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09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
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10197344169412MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
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10197344169467MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169474MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
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10197344169498MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169504MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
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