FDA.reportPublic FDA data

Skinsafe Plus

Primary DI
05059884010372
Brand
Skinsafe Plus
Company
SPECIALITY FIBRES AND MATERIALS LIMITED
Model
Skinsafe Plus 120 10x12.5
Catalog number
FP650665
Device description
Skinsafe Plus 120 10x12.5
Published
2023-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05059884010372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05059884010372050598840103725059884010372

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-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; it does not contain an antimicrobial agent. The device 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. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
219041423
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05059884010938DURAFIBER Ag PRO 10x12cmFV001021660276822026-02-09
05059884010945DURAFIBER Ag PRO 15x15cmFV001022660276792026-02-09
05059884010952DURAFIBER Ag PRO 5x5cmFV001023660276772026-02-09
05059884010969DURAFIBER Ag PRO 20x30cmFV001024660276802026-02-09
05059884010976DURAFIBER Ag PRO 2x45cmFV001025660276812026-02-09
05059884010921DURAFIBER Ag PRO 10x10cmFV001020660276782026-02-09
15059884010935DURAFIBER Ag PRO 10x12cmFV001021660276822026-02-09
15059884010942DURAFIBER Ag PRO 15x15cmFV001022660276792026-02-09
15059884010959DURAFIBER Ag PRO 5x5cmFV001023660276772026-02-09
15059884010966DURAFIBER Ag PRO 20x30cmFV001024660276802026-02-09
15059884010973DURAFIBER Ag PRO 2x45cmFV001025660276812026-02-09
05060786987549Skinsafe Plus AgSkinsafe Plus Ag 120 5x5FT6506662023-11-14
05060786987556Skinsafe Plus AgSkinsafe Plus Ag 120 10x12.5FT6506672023-11-14
05060786981462Suprasorb ASuprasorb A L130 10x10cm204412024-05-22
05060786981479Suprasorb ASuprasorb A L130 10x12.5cm309902024-05-22
05060786981486Suprasorb ASuprasorb A L130 10x20cm204422024-05-22
05060786981493Suprasorb ASuprasorb A L130 2x30cm204452024-05-22
05060786981509Suprasorb ASuprasorb A L130 5x5cm204402024-05-22
05059884010365Skinsafe PlusSkinsafe Plus 120 5x5FP6506642023-11-14

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Primary DI, Brand, Company table
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