FDA.reportPublic FDA data

Suprasorb P Sensitive Ag

Primary DI
04063591428031
Brand
Suprasorb P Sensitive Ag
Company
L&R USA INC.
Model
10cm x 10cm with border
Catalog number
180011
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
04063591428031PackageGS110In Commercial Distribution
04063591428048PackageGS120In Commercial Distribution
04063591428055PackageGS11In Commercial Distribution
04063591428024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04063591428031040635914280314063591428031
04063591428048040635914280484063591428048
04063591428055040635914280554063591428055
04063591428024040635914280244063591428024

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
false
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
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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