FDA.reportPublic FDA data

Armor Gel

Primary DI
00851213004237
Brand
Armor Gel
Company
Abl Medical, LLC
Model
4 oz
Device description
Armor Gel Wound Dressing Gel, 4 oz
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
K140483000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140483000ASAP OTC WOUND DRESSING GELAbl Medical, LLC2014-05-20FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851213004244PackageGS112In Commercial Distribution
00851213004237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851213004244008512130042448512130042440851213004244
00851213004237008512130042378512130042370851213004237

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight113Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(801)763-8000info@ablmedical.com

Regulatory Flags#

DUNS number
078644765
Device count
1
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
00831060006318Carestat1 oz2023-01-30
00851213004695Silvrstat4 FL OZ2022-12-13
00851213004428Armor Gel Canadian1.5 oz2022-12-09
00851213004138Silvrstat.5 oz2022-12-07
00851213004190ASAP OTC1.5 oz2022-12-07
00851213004213ASAP OTC4 oz2022-12-07
00851213004251Armor Gel1.5 oz2022-12-07
00851213004282ASAP OTC5 gram2022-12-07
00851213004299Armor Gel5 gram2022-12-07
00851213004329Armor Gel.5 oz2022-12-07
00851213004350Silvrstat5 gram2022-12-07

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Primary DI, Brand, Company table
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10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
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10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
06977727072259Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072266Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
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