FDA.reportPublic FDA data

CovaWound Alginate Ag 10x10cm

Primary DI
00825439012161
Brand
CovaWound Alginate Ag 10x10cm
Company
Covalon Technologies Ltd
Model
3101010
Device description
Alginate dressing with silver
Published
2022-12-01
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
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071442000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071442000SUPRASORB A +AGSpecialty Fibres and Materials, Ltd.2008-05-01FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00825439012178PackageGS110In Commercial Distribution
10825439012236PackageGS120In Commercial Distribution
00825439012161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00825439012178008254390121788254390121780825439012178
1082543901223610825439012236
00825439012161008254390121618254390121610825439012161

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Centimeter
Width10Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
206936101
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00825439012062MediClear™ Scar 10x10900101090010102023-07-14
00825439012260MediClear™ Scar 4x4900040490004042023-07-14
00825439012291MediClear™ Scar 6x7900060790006072023-07-14
00825439012321MediClear™ Scar 6x30900063090006302023-07-14
00825439012789MediClear™ PreOp 70010122018-04-30
00825439012819MediClear PreOp70006302022-12-01
00825439012994MediClear PreOp70006252022-12-01
00825439016169MediClear™ PreOp70008302018-05-18
00825439012871MediClear™ PreOp70006072018-04-30
00825439010136IV Clear 4x4 with crosshairTWBD10112022-11-30
00825439010334SurgiClear 4x4TWBD10222022-12-01
00825439010464IV Clear 4x4TWBD10132022-11-30
00825439011188"ColActive® Plus 2""x2"""55502202022-11-30
00825439011218"ColActive® Plus 4""x4"""55504402022-11-30
00825439011249"ColActive® Plus 7""x7"""55507702022-11-30
00825439011270"ColActive® Plus Ag 2""x2"""55512202022-11-30
00825439011300"ColActive® Plus Ag 4""x4"""55514402022-11-30
00825439011331"ColActive® Plus Ag 7""x7"""55517702022-11-30
00825439013472ColActive® Transfer 4x455504412022-12-05
00825439017241ColActive® Plus Powder80P00012022-11-30

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00852421007300Pure&CleanPure & Clean, LLCFRO2026-07-22
00818582012867Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
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00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
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10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
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10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
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10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
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