FDA.reportPublic FDA data

Simpurity

Primary DI
00008140135941
Brand
Simpurity
Company
SAFE N' SIMPLE LLC
Model
SNS52245
Catalog number
SNS52245
Device description
"Collagen Dressing 4"" x 5"""
Published
2026-02-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGNWound Dressing With Animal-Derived Material(S)

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
00008140135941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00008140135941000081401359410081401359410008140135941

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
248 214 4877amy@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
10810040131872SimpuritySNS52277SNS522772025-06-17
10810040135955SimpuritySNS52245SNS522452025-06-17
20810040131879SimpuritySNS52277SNS522772025-06-17
00810040135699SimpuritySNS51222SNS512222025-06-17
00810040135705SimpuritySNS51222SNS512222025-06-17
00810040135712SimpuritySNS51244SNS512442025-06-17
00810040135729SimpuritySNS51244SNS512442025-06-17
00810040135958SimpuritySNS52245SNS522452025-06-17
00854261007564SimpuritySNS51222SNS512222025-06-17
00854261007571SimpuritySNS51244SNS512442025-06-17
00810040135941SimpuritySNS52245SNS522452025-06-17
00810040131875SimpuritySNS52277SNS522772025-06-17
00850004779798SimpuritySNS52222SNS522222021-11-30
00854261007588SimpuritySNS52244SNS522442021-11-30
00896005002428SimpuritySNS50002SNS500022021-11-30
00850004779286SimpuritySNS52244SNS522442019-08-12
00850004779743SimpuritySNS50002SNS500022019-08-12
00850004779804SimpuritySNS52222SNS522222019-08-12
10810040131896SimpuritySNS52377SNS523772025-06-17
10810040135740SimpuritySNS74068SNS740682025-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084084010CURCOFR TECH, LLCKGN2026-06-02
00850084084027CURCOFR TECH, LLCKGN2026-06-02
00850084084034CURCOFR TECH, LLCKGN2026-06-02
00850084084041CURCOFR TECH, LLCKGN2026-06-02
00850084084058CURCOFR TECH, LLCKGN2026-06-02
00850084084065CURCOFR TECH, LLCKGN2026-06-02
00850084084072CURCOFR TECH, LLCKGN2026-06-02
00850084084089CURCOFR TECH, LLCKGN2026-06-02
00714196003317DermaCol 100 Gel 1oz TubeSion Brands LLCKGN2026-06-01
07610221017737Derma-Gide®Geistlich Pharma AGKGN2026-06-01
00813954028385collateneCOLLAGEN MATRIX, INC.KGN2026-05-05
10840330705858ProCureTwin Med, LLCKGN2026-05-04
10840330705834ProCureTwin Med, LLCKGN2026-04-28
10840330705841ProCureTwin Med, LLCKGN2026-04-28
00812593023119NeoForm AWCBiogennix, LLCKGN2026-04-27
00812593023126NeoForm AWCBiogennix, LLCKGN2026-04-27
00812593023072NeoSurg Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023089ossFX Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023096ossFX Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023102ColSyntekBiogennix, LLCKGN2026-04-22
10885632434280HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-04-16
10885632434297HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-04-16
00324357900012Zeni MedicalFocus Health Group, Inc.KGN2026-04-13
00324357900777Zeni MedicalFocus Health Group, Inc.KGN2026-04-13
00812593023058Agilon Surgical Collagen +Biogennix, LLCKGN2026-04-02
00812593023065Agilon Surgical Collagen +Biogennix, LLCKGN2026-04-02
00812593023034CuraSurg Surgical CollagenBiogennix, LLCKGN2026-04-01
00812593023041CuraSurg Surgical CollagenBiogennix, LLCKGN2026-04-01
10885632434273HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-03-31
16942327004853DimoraWinner Medical Co., Ltd.KGN2026-03-30