FDA.reportPublic FDA data

Silver-sept Silver Antimicrobial Skin and Wound Gel

Primary DI
00367180312157
Brand
Silver-sept Silver Antimicrobial Skin and Wound Gel
Company
ANACAPA TECHNOLOGIES, INC.
Model
3015S
Catalog number
3015S
Device description
Silver-sept® Antimicrobial Skin and Wound Gel, containing 200ug/gram total silver, is a clear amorphous hydrogel wound dressing. Silver-sept will not stain or discolor tissue. Silver-sept® gel functions as a long-lasting antimicrobial barrier by inhibiting the growth of common bacteria such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens including the antibiotic resistant strains Methicillin resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus faecalis (VRE) as well as fungi such as Candida albicans and Aspergillus niger.
Published
2020-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

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
K062212000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062212000SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-SAnacapa Technologies, Inc.2006-11-21FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00367180312157PackageGS112In Commercial Distribution
00367180300154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00367180312157003671803121573671803121570367180312157
00367180300154003671803001543671803001540367180300154

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
Weight43Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9093947795anacapa@anacapa-tech.net

Regulatory Flags#

DUNS number
073189370
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00367180400083Anasept Antimicrobial Skin and Wound Cleanser4008C4008C2020-06-22
00367180400120Anasept Antimicrobial Skin and Wound Cleanser4012SC4012SC2020-06-08
00367180400168Anasept Antimicrobial Skin and Wound Cleanser4016C4016C2020-07-28
00367180400885Anasept Antimicrobial Skin and Wound Cleanser4008SC4008SC2020-06-08
00367180408881Anasept Antimicrobial Skin and Wound Cleanser4008TC4008TC2020-06-22
00367180416169Anasept Antimicrobial Wound Irrigation Solution4160IC4160IC2020-06-22
00367180412888Anasept Antimicrobial Skin and Wound Cleanser4008SC4008SC2020-06-08
00367180400441Anasept Antimicrobial Skin and Wound Cleanser4004SC4004SC2020-08-28
00367180400045Anasept Antimicrobial Skin and Wound Cleanser4004C4004C2020-07-29
00367180300154Silver-sept Silver Antimicrobial Skin and Wound Gel3015S3015S2020-11-23
00367180300031Silver-sept Silver Antimicrobial Skin and Wound Gel3003S3003S2020-10-22
00367180412161Anasept Antimicrobial Skin and Wound Cleanser4016C4016C2020-07-28
00367180500158Anasept Antimicrobial Skin and Wound Gel5015G5015G2020-07-27
00367180512151Anasept Antimicrobial Skin and Wound Gel5015G5015G2020-07-27
00367180500035Anasept Antimicrobial Skin and Wound Gel5003G5003G2020-07-06
00367180412123Anasept Antimicrobial Skin and Wound Cleanser4012SC4012SC2020-06-08
00367180512038Anasept Antimicrobial Skin and Wound Gel5003G5003G2020-07-06
00367180412086Anasept Antimicrobial Skin and Wound Cleanser4008C4008C2020-06-22
00367180412802Anasept Antimicrobial Skin and Wound Cleanser4008TC4008TC2020-06-22
00367180426168Anasept Antimicrobial Wound Irrigation Solution4160IC4160IC2020-06-22

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