FDA.reportPublic FDA data

KerraCel Ag

Primary DI
05060077233508
Brand
KerraCel Ag
Company
CRAWFORD HEALTHCARE LIMITED
Model
2 x 2in
Catalog number
CWL1157
Published
2019-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K162508000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162508000KerraCel Ag Gelling Fiber Silver DressingExciton Technologies, Inc.2017-02-13FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060077233515PackageGS110In Commercial Distribution
05060077233522PackageGS110In Commercial Distribution
05060077233508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060077233515050600772335155060077233515
05060077233522050600772335225060077233522
05060077233508050600772335085060077233508

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
Height2Inch
Length2Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Store out of direct sunlight
Storage Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+4401565654920elizabeth.woods@acelity.com
+4401565654920andrew.jackson@acelity.com

Regulatory Flags#

DUNS number
543740310
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060077231306KerraCel2 x 2inCWL10322019-10-01
05060077231320KerraCel4 x 5inCWL10332019-10-01
05060077231368KerraCel1 x 18 inCWL10352019-10-01
05060077233539KerraCel Ag4 x 5inCWL11582019-10-01
05060077233560KerraCel Ag6 x 6inCWL1159 2019-10-01
05060077233591KerraCel Ag8 x 12inCWL11602019-10-01
05060077233652KerraCel Ag0.75 x 18inCWL11622019-10-01
05060077233683KerraCel Ag16 x 16inCWL11632019-10-01
05060077233744KerraCel4 x 4inCWL11662019-10-01
05060077233973KerraCel Ag0.75 x 12inCWL11682019-10-01
05060077231344KerraCel6 x 6inCWL10342019-10-01
05060077230828KerraFoam Gentle Border3 x 3inCWL10102019-10-01
05060077230835KerraFoam Gentle Border4 x 4inCWL10112019-10-01
05060077230842KerraFoam Gentle Border4 x 8inCWL10122019-10-01
05060077230859KerraFoam Gentle Border5 x 5inCWL10132019-10-01
05060077230989KerraFoam Gentle Border9.8 x 9inCWL10242019-10-01
05060077230996kerraFoam Gentle Border6.7 x 6.9inCWL10232019-10-01
05060077231382KerraFoam Gentle Border9 x 10inCWL10402019-10-01
05060077232464KerraFoam Gentle Border6 x 6inCWL11322019-10-01
05060077232495KerraFoam Gentle Border4 x 10inCWL11332019-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850039735363MendER Antimicrobial Wound GelSilverceuticals IncFRO2026-10-26
00850039735370TG-32 Antimicrobial Wound GelSilverceuticals IncFRO2026-10-26
00850039735387TG-32 Antimicrobial Wound GelSilverceuticals IncFRO2026-10-26
00850039735394MendER Antimicrobial Wound GelSilverceuticals IncFRO2026-10-26
00197998307386Solventum™ Actisorb™ Silver 220Solventum Germany GmbHFRO2026-10-22
00197998307423Solventum™ Actisorb™ Silver 220Solventum Germany GmbHFRO2026-10-22
00197998307461Solventum™ Actisorb™ Silver 220Solventum Germany GmbHFRO2026-10-22
10080196299850MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-10-22
00818582013628Puracyn Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.FRO2026-10-16
05059884011164Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011171Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011188Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011195Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011201Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011218Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011225Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
00841277111378Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111385Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111392Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111408Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111382Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
00050428034712CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428034743CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428142349CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428341728CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214820DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214837DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09