FDA.report

Simpurity

Primary DI
00854261007663
Brand
Simpurity
Company
SAFE N' SIMPLE LLC
Model
SNS77744
Catalog number
SNS77744
Device description
Foam Dressing 4 x 4 inch with Silicone Adhesive Border (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
NACDressing, Wound, Hydrophilic

Product Code Classifications

CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00854261007663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00854261007663008542610076638542610076630854261007663

GMDN Terms

TermDefinition
Wound-nonadherent dressing, permeable, non-antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.

Device Sizes

TypeValueUnit
Height4Inch
Length4Inch

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

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00810040135828SimpuritySNS58318SNS583182025-06-17
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00810040135927SimpuritySNS54414SNS544142025-06-17
00810040135941SimpuritySNS52245SNS522452025-06-17
00810040135965SimpuritySNS52044SNS520442025-06-17
00810040135989SimpuritySNS52045SNS520452025-06-17
00810040136009SimpuritySNS52036SNS520362025-06-17

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