FDA.reportPublic FDA data

DURAFIBER 10X10 CTN 10

Primary DI
05000223466947
Brand
DURAFIBER 10X10 CTN 10
Company
SMITH & NEPHEW MEDICAL LIMITED
Model
66800560
Catalog number
66800560
Device description
Absorbent gelling fibrous dressing
Published
2020-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
05000223466947PackageGS110In Commercial Distribution
05000223466954PackageGS112In Commercial Distribution
05000223466695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05000223466947050002234669475000223466947
05000223466954050002234669545000223466954
05000223466695050002234666955000223466695

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, sterileA sterile wound covering, typically made of a hydrocolloid, hydrofibre, 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
216344051
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
05000223503956LEAF66807739668077392026-03-03
05000223503994LEAF66807745668077452026-03-01
00040565117706COVRSITE5971400059714000 / 597141002026-01-19
00040565117744COVRSITE5971430059714300 / 597144002026-01-19
00040565120256COVRSITE59715000597150002026-01-19
00040565120270COVRSITE59715100597151002026-01-19
00500223504335NOVIX66027708660277082026-01-13
05000223502713No Sting Skin Prep66807691668076912025-11-26
05000223499389RENASYS66803107668031072025-09-23
05000223499396RENASYS66803106668031062025-09-23
05000223499402RENASYS66803105668031052025-09-23
05000223504267RENASYS66807737668077372025-09-23
05000223504274RENASYS66807736668077362025-09-23
05000223504281RENASYS66807735668077352025-09-23
05000223501686ALLEVYN™ Ag+66027663660276632025-08-12
05000223501693ALLEVYN™ Ag+66027664660276642025-08-12
05000223501709ALLEVYN™ Ag+66027665660276652025-08-12
05000223501808ALLEVYN™ Ag+66027669660276692025-08-12
05000223501815ALLEVYN™ Ag+66027670660276702025-08-12
05000223503178ALLEVYN COMPLETE CARE66807697668076972025-07-30

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Primary DI, Brand, Company table
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07333350625993Mepore®Mölnlycke Health Care ABNAC2026-05-23
00361554003412Silicone Superabsorbent Bordered DressingGentell, LLCNAC2026-05-19
00361554003436Silicone Superabsorbent Bordered DressingGentell, LLCNAC2026-05-19
00361554003450Silicone Superabsorbent Bordered DressingGentell, LLCNAC2026-05-19
20197344025340MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-03-13
30197344016840MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-03-06
30197344016857MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-03-06
07333350045845Mepilex® TransferMölnlycke Health Care ABNAC2026-02-26
07333350416249Mepilex® TransferMölnlycke Health Care ABNAC2026-02-26
20665973033024DukalDukal LLCNAC2026-02-26
00197998275326Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998275951Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00197998275999Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
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00197998276071Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
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00197998276316Solventum™ Kerramax Care™Solventum US LLCNAC2026-02-15
00810178883646ViveCareVIVE HEALTH LLCNAC2026-02-05
00810178883653ViveCareVIVE HEALTH LLCNAC2026-02-05
00810178883660ViveCareVIVE HEALTH LLCNAC2026-02-05
00810178883677ViveCareVIVE HEALTH LLCNAC2026-02-05
20197344016812MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-02-05
20197344016836MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-02-05
00198926007453OrchidQuest USA Corp.NAC2026-02-03
00198926007460OrchidQuest USA Corp.NAC2026-02-03