FDA.reportPublic FDA data

Suprasorb A+Ag

Primary DI
20744084000641
Brand
Suprasorb A+Ag
Company
L&R USA INC.
Model
5cm x 5cm
Catalog number
32755
Published
2021-09-17
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20744084000641PackageGS19In Commercial Distribution
10744084000644PrimaryGS10
00744084000647Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2074408400064120744084000641
1074408400064410744084000644
00744084000647007440840006477440840006470744084000647

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, 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 Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
849081406
Device count
10
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
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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Primary DI, Brand, Company table
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01714196222045DermaRite Medical DermaHoney Tulle Non Border Honey Gauze 4x4Sion Brands LLCFRO2026-06-01
01714196333048DermaRite Medical DermaHoney Border Medical Grade Honey Sheet 4x4Sion Brands LLCFRO2026-06-01
08717249680130DermaRite Medical L-Mesitran 0.5 oz TubeSion Brands LLCFRO2026-06-01
08717249680147DermaRite Medical L-Mesitran 1.75 oz TubeSion Brands LLCFRO2026-06-01
00850087488259CeeportCEEPORT INC.FRO2026-05-29
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10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
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