FDA.reportPublic FDA data

Suprasorb P Heel

Primary DI
04063591522531
Brand
Suprasorb P Heel
Company
L&R USA INC.
Model
13cm x 10cm non-adhesive
Catalog number
180040
Published
2023-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04063591522524PackageGS15In Commercial Distribution
04063591522531PackageGS1120In Commercial Distribution
04063591522579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04063591522524040635915225244063591522524
04063591522531040635915225314063591522531
04063591522579040635915225794063591522579

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, non-antimicrobialA wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from light
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
849081406
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
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
04063591428079Suprasorb P Sensitive Ag15cm x 15cm with border1800132021-09-15
04063591428116Suprasorb P Sensitive Ag20cm x 20cm with border1800142021-09-15

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