FDA.reportPublic FDA data

GoodSense

Primary DI
00180410000880
Brand
GoodSense
Company
GEISS, DESTIN & DUNN, INC
Model
180410000880
Device description
Sterile Pads, all one size, 3 IN x 3 IN (76 mm x 76 mm)
Published
2020-08-28
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
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10180410000887PackageGS172In Commercial Distribution
00180410000880PrimaryGS10
60180410000882Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1018041000088710180410000887
00180410000880001804100008801804100008800180410000880
6018041000088260180410000882

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze padA non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum; in some cases, the device’s packaging may be used as a disposable tray. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
8558234545xx@xx.xx

Regulatory Flags#

DUNS number
076059836
Device count
10
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846036009453GOODSENSEG6009452025-01-16
00846036209457GOODSENSEG6009452025-01-16
00846036009446GOODSENSEG6009442022-05-03
00846036006438Good Sense69-3522016-09-23
00846036007671Good Sense69-3582016-09-23
00846036009774GOODSENSEG6009772025-01-16
00180410000897GoodSense1804100008972020-08-28
00846036009606Good SenseKC009609MPSA1201GSGS2024-02-13
00846036006391Good Sense One Step Pregnancy TestFPPL2016-06-30
00846036009170Good SenseOne Step Pregnancy Test2020-09-21
00846036009187Good SenseOne Step Pregnancy Test2020-09-21
00846036006179Good Sense Early Result Pregnancy TestPLPL2016-06-30
00846036006186Good Sense Early Result Pregnancy TestPLPL2016-06-30
00846036006407Good Sense One Step Pregnancy TestFPPL2016-06-30
00846036002034Good SenseDS00203DS002032022-06-21
10846036002031Good SenseDS00203DS002032022-06-21
00846036000184Good Sense TamponsBGSAS202016-09-20
00846036000337Good Sense TamponsBGSAR082016-09-20
00846036003161Good Sense TamponsBGSGR202016-09-20
00846036004083Good Sense TamponsBGSGS182016-09-20

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