FDA.report

Simpurity

Primary DI
00896005002633
Brand
Simpurity
Company
SAFE N' SIMPLE LLC
Model
SNS58802
Catalog number
SNS58802
Device description
Impregnated Hydrogel Gauze Dressing 2 x 2 inch (Each)
Published
2021-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications

CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00896005002633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00896005002633008960050026338960050026330896005002633

GMDN Terms

TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Device Sizes

TypeValueUnit
Height2Inch
Length2Inch

Sterilization Methods

Method

Contacts

PhoneEmail
2482144877amy@sns-medical.com

Regulatory Flags

DUNS number
807812412
Device count
1
DM exempt
false
Premarket exempt
true
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 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 DIBrandCompanyProduct codePublished
06975278040017delay sprayJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040024delay sprayJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040031delay cream/delay balm for menJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040048vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040055vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040062vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040079vaginal intense climax liquid/pleasure gelJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040086vaginal pleasure liquibead/climax intense liquibeadJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040116vaginal virgin gel/tightening gel creamJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040123vaginal virgin gel/tightening gel creamJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
06975278040130vaginal virgin gel/tightening gel creamJiaoyue Pharmaceuticals (Huizhou) Co., Ltd.NAE2026-02-22
00743537000449First ResponderWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00743537000715MilitaryWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00860000562539LaviorLavior Pharma Inc.NAE2026-02-14
00860007877766LaviorLavior Pharma Inc.NAE2026-02-14
00860007877773LaviorLavior Pharma Inc.NAE2026-02-14
00860010195727LaviorLavior Pharma Inc.NAE2026-02-14
00860010195741LaviorLavior Pharma Inc.NAE2026-02-14
00850072068749CeladiaBiowound Solutions, Inc.NAE2025-12-18
06972864363031sknjxNingbo Chinmed Technology Co., Ltd.NAE2025-12-16
50192253040157KendallCardinal Health 200, LLCNAE2025-09-26
00197998326905Solventum™ Nu-Gel™Solventum US LLCNAE2025-09-22
00197998326981Solventum™ Nu-Gel™Solventum US LLCNAE2025-09-22
00858071004348Advanced Shield Hydrogel Silver Wound Barrier GEL, 2oz TubeKericure Inc.NAE2025-08-26
07290101428350Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDNAE2025-08-25
72901014283670Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDNAE2025-08-25
15056860000072Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000089Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
00858071004317Advanced Shield Chronic Wound Care, 2ozKericure Inc.NAE2025-08-08
00860000495097Altrazeal Transforming Powder DressingAltrazeal Life Sciences Inc.NAE2025-08-07