FDA.reportPublic FDA data

SOLIDEA

Primary DI
08300496042235
Brand
SOLIDEA
Company
CALZIFICIO PINELLI SRL
Model
042235
Catalog number
043070
Device description
ALISEA 70, SIZE M, MOKA, GRADUATED COMPRESSION 12/15 mmHg TIGHTS WITH GEOMETRIC PATTERN
Published
2020-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FQAScale, Surgical Sponge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQAScale, Surgical SpongeGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08300496042235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08300496042235083004960422358300496042235

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, reusableA garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
431221795
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08300496073765SOLIDEA0737650619A52026-10-16
08300496073772SOLIDEA0737720619A52026-10-16
08300496073789SOLIDEA0737890619A52026-10-16
08300496073796SOLIDEA0737960619A52026-10-16
08300496073802SOLIDEA0738020619A52026-10-16
08300496073819SOLIDEA0738190619A52026-10-16
08300496073826SOLIDEA0738260620A52026-10-16
08300496073833SOLIDEA0738330620A52026-10-16
08300496073840SOLIDEA0738400620A52026-10-16
08300496073857SOLIDEA0738570620A52026-10-16
08300496073864SOLIDEA0738650620A52026-10-16
08300496073871SOLIDEA0738710620A52026-10-16
08300496073888SOLIDEA0738880656B82026-10-16
08300496073895SOLIDEA0738950656B82026-10-16
08300496073901SOLIDEA0739010656B82026-10-16
08300496073918SOLIDEA0739180656B82026-10-16
08300496073925SOLIDEA0739250656B82026-10-16
08300496073932SOLIDEA0739320656B82026-10-16
08300496073949SOLIDEA0739490656B82026-10-16
08300496073956SOLIDEA0739560656B82026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849987000043SR ScalesS R INSTRUMENTS, INC.FQA2026-06-23
00849987000050SR ScalesS R INSTRUMENTS, INC.FQA2026-06-23
00849987001408SR ScalesS R INSTRUMENTS, INC.FQA2026-06-23
00849987001415SR ScalesS R INSTRUMENTS, INC.FQA2026-06-23
00849987001422SR ScalesS R INSTRUMENTS, INC.FQA2026-06-23
00849987001439SR ScalesS R INSTRUMENTS, INC.FQA2026-06-23
00849987001453SR ScalesS R INSTRUMENTS, INC.FQA2026-06-23
00849987001507SR ScalesS R INSTRUMENTS, INC.FQA2026-06-23
00849987002849SR ScalesS R INSTRUMENTS, INC.FQA2026-06-23
00849987002863SR ScalesS R INSTRUMENTS, INC.FQA2026-06-23
00850013361441Doran ScalesDORAN SCALES, INC.FQA2023-11-14
0078755101230950500 Sponge Counter Bag BlueXODUS MEDICAL, INC.FQA2022-12-08
0078755101234750510 Single Dispenser Rack Two Sets of Hooks In Front Wall & IV PoleXODUS MEDICAL, INC.FQA2022-12-08
0078755101235450511 Double Dispenser Rack Four Sets of Hooks IV Pole OnlyXODUS MEDICAL, INC.FQA2022-12-08
0078755101239250600 Sponge Counter Bags ClearXODUS MEDICAL, INC.FQA2022-12-08
00850013361250Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361267Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361274Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361281Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361298Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361304Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361403Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361410Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00850013361427Doran ScalesDORAN SCALES, INC.FQA2022-05-31
00809161142709DetectoCARDINAL SCALE MANUFACTURING COMPANYFQA2017-10-18
00809161201901DetectoCARDINAL SCALE MANUFACTURING COMPANYFQA2017-10-18
00849686073669NoninNONIN MEDICAL, INC.FQA2017-02-22
00833166008722NoninNONIN MEDICAL, INC.FQA2017-02-22