FDA.reportPublic FDA data

Simpurity

Primary DI
00850004779545
Brand
Simpurity
Company
SAFE N' SIMPLE LLC
Model
SNS59080
Catalog number
SNS59080
Device description
Super Absorbent Polymer Dressing 5 x 9 inch
Published
2019-08-13
Public version status
Update
Distribution status
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
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004779545PrimaryGS10
00850004779538Unit of UseGS10
00850004779552Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004779545008500047795458500047795450850004779545
00850004779538008500047795388500047795380850004779538
00850004779552008500047795528500047795520850004779552

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, sterileA sterile wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel) that prevents adherence to the wound bed, thereby decreasing the potential for wound trauma; it does not contain an antimicrobial agent. It is typically used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height5Inch
Length9Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
807812412
Device count
10
Premarket exempt
true
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
00008140135941SimpuritySNS52245SNS522452026-02-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10885632506017HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-06-05
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00850087488280CeeportCEEPORT INC.NAD2026-05-29
00850087488297CeeportCEEPORT INC.NAD2026-05-29
00850087488365CeeportCEEPORT INC.NAD2026-05-29
00850087488372CeeportCEEPORT INC.NAD2026-05-29
00850087488396CeeportCEEPORT INC.NAD2026-05-29
00850087488402CeeportCEEPORT INC.NAD2026-05-29
00850087488419CeeportCEEPORT INC.NAD2026-05-29
10840330701560ProCureTwin Med, LLCNAD2026-04-28
10840330701577ProCureTwin Med, LLCNAD2026-04-28
10840330701584ProCureTwin Med, LLCNAD2026-04-28
10840330701591ProCureTwin Med, LLCNAD2026-04-28
10840330701607ProCureTwin Med, LLCNAD2026-04-28
10840330701614ProCureTwin Med, LLCNAD2026-04-28
10840330701621ProCureTwin Med, LLCNAD2026-04-28
10840330701638ProCureTwin Med, LLCNAD2026-04-28
10840330701645ProCureTwin Med, LLCNAD2026-04-28
10840330701652ProCureTwin Med, LLCNAD2026-04-28
10840330701669ProCureTwin Med, LLCNAD2026-04-28
00324357200457Zeni MedicalFocus Health Group, Inc.NAD2026-04-13
00324357200488Zeni MedicalFocus Health Group, Inc.NAD2026-04-13
00324357200884Zeni MedicalFocus Health Group, Inc.NAD2026-04-13
00324357404145Zeni MedicalFocus Health Group, Inc.NAD2026-04-13
00324357410078Zeni MedicalFocus Health Group, Inc.NAD2026-04-13
10193489093902MEDLINEMEDLINE INDUSTRIES, INC.NAD2026-01-29
10735471024695PolyMemFERRIS MFG. CORP.NAD2026-01-14
10197344169566MEDLINEMEDLINE INDUSTRIES, INC.NAD2025-12-12
10192253038811KendallCardinal Health 200, LLCNAD2025-11-21