FDA.reportPublic FDA data

Orasoothe Sockit Gel Syringe

Primary DI
10303620002070
Brand
Orasoothe Sockit Gel Syringe
Company
SEPTODONT SAS SPECIALITES SEPTODONT
Model
01S0600
Catalog number
01S0600
Device description
dressing wound
Published
2022-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10303620002070PrimaryGS10
00303620002073Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030362000207010303620002070
00303620002073003036200020733036200020730303620002073

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
275273795
Device count
5
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00303620001434Septodont Multi-Use Dispenser01C20562025-05-29
14719871634322Biodentine Mixer01C072501C07252025-04-25
03760140703359RACEGEL01C050001C05002016-09-12
03760140703243CIMPAT PINK01E011001E01102016-09-12
03760140703250CIMPAT WHITE01E012001E01202016-09-12
07897990328435SeptoWedges Refill: 100 Asst. wooden wedges01C402001C40202022-12-19
07897990328459SeptoMatrix Sectional Refill: 50 assorted matrices01C401401C40142022-12-16
07897990328466SeptoMatrix Sectional Refill: 50 large matrices01C401501C40152022-12-16
07897990328473SeptoMatrix Sectional Refill: 50 medium matrices01C401601C40162022-12-16
07897990328480SeptoMatrix Sectional Refill: 50 small matrices01C401701C40172022-12-16
07897990328718SeptoPlus Mandrel Refill: 1 mandrel snap01C403101C40312022-12-19
07897990328725SeptoDiscs Kit: 120 assorted abrasive discs+ mandrel pop-on01C400101C40012022-12-16
07897990328732SeptoDiscs Refill:1/2” 50 assorted abrasive discs01C400201C40022022-12-16
07897990328749SeptoDiscs Refill:1/2” 50 coarse abrasive discs01C400301C40032022-12-16
07897990328756SeptoDiscs Refill:1/2” 50 medium abrasive discs01C400401C40042022-12-16
07897990328763SeptoDiscs Refill: 1/2” - 50 fine abrasive discs01C400501C40052022-12-16
07897990328770SeptoDiscs Refill: 1/2” - 50 extra fine abrasive discs01C400601C40062022-12-16
07897990329081SeptoWedges Refill: 100 wooden wedges n°1-yellow01C402101C40212022-12-19
07897990329098SeptoWedges Refill: 100 wooden wedges n°2-blue01C402201C40222022-12-19
07897990329104SeptoWedges Refill: 100 wooden wedges n°3-red01C402301C40232022-12-19

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