FDA.reportPublic FDA data

Simpurity

Primary DI
00850004779798
Brand
Simpurity
Company
SAFE N' SIMPLE LLC
Model
SNS52222
Catalog number
SNS52222
Device description
Collagen Dressing 2 x 2 inches (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
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004779798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004779798008500047797988500047797980850004779798

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
Height2Inch
Length2Inch

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00008140135941SimpuritySNS52245SNS522452026-02-10
00810040130632SimpuritySNS51W08SNS51W082025-06-17
00810040134401SimpuritySNS58825SNS588252025-06-17
00810040135750SimpuritySNS74816SNS748162025-06-17
00810040135880SimpuritySNS54044SNS540442025-06-17
00854261007564SimpuritySNS51222SNS512222025-06-17
00854261007571SimpuritySNS51244SNS512442025-06-17
00810040135736SimpuritySNS74068SNS740682025-06-17
00810040135781SimpuritySNS58018SNS580182025-06-17
00810040135804SimpuritySNS58039SNS580392025-06-17
00810040135828SimpuritySNS58318SNS583182025-06-17
00810040135842SimpuritySNS58336SNS583362025-06-17
00810040135866SimpuritySNS54410SNS544102025-06-17
10810040135894SimpuritySNS54044SNS540442025-06-17
00810040135903SimpuritySNS54046SNS540462025-06-17
00810040135927SimpuritySNS54414SNS544142025-06-17
00810040135941SimpuritySNS52245SNS522452025-06-17
00810040135965SimpuritySNS52044SNS520442025-06-17
00810040135989SimpuritySNS52045SNS520452025-06-17
00810040136009SimpuritySNS52036SNS520362025-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954028873PuraKOTE+COLLAGEN MATRIX, INC.KGN2026-05-26
00813954028880PuraPLUG+COLLAGEN MATRIX, INC.KGN2026-05-26
00813954028897PuraTAPE+COLLAGEN MATRIX, INC.KGN2026-05-26
10885632434303HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-05-22
00812593023010Agilon Surgical Collagen+Biogennix, LLCKGN2026-03-24
00812593023027Agilon Surgical Collagen+Biogennix, LLCKGN2026-03-24
30888277720729MEDLINEMEDLINE INDUSTRIES, INC.KGN2026-03-10
20888277720739MEDLINEMEDLINE INDUSTRIES, INC.KGN2026-03-10
10813954028436Tissue Specialists Resorbable Collagen PlugCOLLAGEN MATRIX, INC.KGN2026-03-09
10813954028443Tissue Specialists Resorbable Collagen TapeCOLLAGEN MATRIX, INC.KGN2026-03-09
10813954028559bioPLUGCOLLAGEN MATRIX, INC.KGN2026-03-09
10381780545569PriMatrix®INTEGRA LIFESCIENCESKGN2026-03-04
00861092002637Cealogic RibbonRECIBIO, INC.KGN2026-03-01
00854780005515Architect FxHARBOR MEDTECH, INC.KGN2026-02-25
00813909013589Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013596Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013602Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013619Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013657Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013664Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013671Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00813909013695Wound MatrixNOVABONE PRODUCTS, LLCKGN2026-02-17
00008140135941SimpuritySAFE N' SIMPLE LLCKGN2026-02-10
08600103725002ReyaGelSTEMSYS LLCKGN2026-02-02
05694310968003Kerecis MariGen®KERECIS hf.KGN2026-01-30
05694310968027Kerecis MariGen®KERECIS hf.KGN2026-01-30
05694310968041Kerecis MariGen®KERECIS hf.KGN2026-01-30
05694310968065Kerecis MariGen®KERECIS hf.KGN2026-01-30
05694310968089Kerecis MariGen®KERECIS hf.KGN2026-01-30
05694310968102Kerecis MariGen®KERECIS hf.KGN2026-01-30