FDA.reportPublic FDA data

Simpurity

Primary DI
00850004779286
Brand
Simpurity
Company
SAFE N' SIMPLE LLC
Model
SNS52244
Catalog number
SNS52244
Device description
Collagen Dressing 4 x 4 inches
Published
2019-08-12
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
KGNDressing, Wound, Collagen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122325000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122325000SKINTEMP IIHuman Biosciences, Inc.2012-10-26KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004779286PrimaryGS10
00850004779293Unit of UseGS10
00854261007588Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004779286008500047792868500047792860850004779286
00850004779293008500047792938500047792930850004779293
00854261007588008542610075888542610075880854261007588

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height4Inch
Length4Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature50 Degrees Fahrenheit80 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2482144877amy@sns-medical.com

Regulatory Flags#

DUNS number
807812412
Device count
10
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
00810040130403Safe N Simple LLCSNS684D2SNS684D22026-10-15
00810040130410Safe N Simple LLCSNS684D2SNS684D22026-10-15
00810040130496Safe N Simple LLCSNS21615SNS216152026-10-15
00810040130502Safe N Simple LLCSNS21615SNS216152026-10-15
00810040134265Safe N Simple LLCSNS7135005SNS71350052026-10-15
00810040134296Safe N Simple LLCSNS7126049SNS71260492026-10-15
00810040134302Safe N Simple LLCSNS7135005SNS71350052026-10-15
00810040134326Safe N Simple LLCSNS7153005SNS71530052026-10-15
00810040134333Safe N Simple LLCSNS7153005SNS71530052026-10-15
00810040135583Safe N Simple LLCSNS21222SNS212222026-10-15
00810040135590Safe N Simple LLCSNS21222SNS212222026-10-15
00810040135613Safe N Simple LLCSNS21630SNS216302026-10-15
00810040135620Safe N Simple LLCSNS21630SNS216302026-10-15
00810040135644Safe N Simple LLCSNS21113SNS211132026-10-15
00810040135651Safe N Simple LLCSNS21113SNS211132026-10-15
00810040135675Safe N Simple LLCSNS68112SNS681122026-10-15
00810040135682Safe N Simple LLCSNS68112SNS681122026-10-15
00850002835007Safe N Simple LLCSNS14506SNS145062026-10-15
00850002835014Safe N Simple LLCSNS14506SNS145062026-10-15
00850002835021Safe N Simple LLCSNS14502SNS145022026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07610221017621DermaFormGeistlich Pharma AGKGN2026-10-19
00810226442979Vive CareVIVE HEALTH LLCKGN2026-10-14
00850083365035LaviorLavior Pharma Inc.KGN2026-10-08
00850083365042LaviorLavior Pharma Inc.KGN2026-10-08
00850083365059LaviorLavior Pharma Inc.KGN2026-10-08
00850065122236VitaleCELLERA LLCKGN2026-10-01
00850088144963CARBOUNingbo kehu Medical Technology Co.,Ltd.KGN2026-09-30
00860013117504DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00860013117511DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00850016008190BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008206BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008220BaseMEMViscus Biologics LLCKGN2026-09-21
05694310969468MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969482MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969505MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969529MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969543SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969567SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969581SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969604SurgiClose® CompactKERECIS hf.KGN2026-09-18
00841277111262Novera RenewHarps USA, Inc.KGN2026-08-26
00850086458062MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
00860012016679MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
00810179632403OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632410OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632427OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632434OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632441OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632458OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632465OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31