FDA.reportPublic FDA data

Simpurity

Primary DI
00896005002442
Brand
Simpurity
Company
SAFE N' SIMPLE LLC
Model
SNS5001G
Catalog number
SNS5001G
Device description
Collagen Particles in a Vial 1 gram (Each)
Published
2021-11-30
Public version status
New
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
KOZBeads, Hydrophilic, For Wound Exudate Absorption

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOZBeads, Hydrophilic, For Wound Exudate AbsorptionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896005002442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896005002442008960050024428960050024420896005002442

GMDN Terms#

Term, Definition table
TermDefinition
Collagen haemostatic agent, non-antimicrobialA bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight1Gram

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
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
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
00850048866928CelluhealHuman Biosciences Inc.KOZ2025-11-17
00850048866966Collecule LpHHuman Biosciences Inc.KOZ2025-11-17
00850048866041CelluhealHuman Biosciences Inc.KOZ2023-09-28
00850048866058MedifilHuman Biosciences Inc.KOZ2023-06-19
00850048866126MedifilHuman Biosciences Inc.KOZ2023-06-19
00850048866195MedifilHuman Biosciences Inc.KOZ2023-06-19
00850048866188MedifilHuman Biosciences Inc.KOZ2023-06-19
00896005002435SimpuritySAFE N' SIMPLE LLCKOZ2021-11-30
06936943411150Huibo MedicalHenan Huibo Medical Co.,Ltd.KOZ2020-01-21
06936943411488Huibo MedicalHenan Huibo Medical Co.,Ltd.KOZ2020-01-21
00850004779750SimpuritySAFE N' SIMPLE LLCKOZ2019-08-12
00850004779774SimpuritySAFE N' SIMPLE LLCKOZ2019-08-12