FDA.reportPublic FDA data

Truform®

Primary DI
00048503512514
Brand
Truform®
Company
SURGICAL APPLIANCE INDUSTRIES, INC.
Model
NV4678BG-2L
Published
2025-01-16
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
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)General Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00048503512514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00048503512514000485035125140485035125140048503512514

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, single-useA 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 single-use device.

Regulatory Flags#

DUNS number
004247383
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00048503515379Truform®8875CH-S2026-06-22
00048503515386Truform®8875CH-M2026-06-22
00048503515393Truform®8875CH-L2026-06-22
00048503515416Truform®8875CH-XL2026-06-22
00048503515423Truform®8875CH-2L2026-06-22
00048503515430Truform®8875CH-3L2026-06-22
00048503515447Truform®8875BN-S2026-06-22
00048503515454Truform®8875BN-M2026-06-22
00048503515461Truform®8875BN-L2026-06-22
00048503515478Truform®8875BN-XL2026-06-22
00048503515485Truform®8875BN-2L2026-06-22
00048503515492Truform®8875BN-3L2026-06-22
00048503515508Truform®8875WH-S2026-06-22
00048503515515Truform®8875WH-M2026-06-22
00048503515522Truform®8875WH-L2026-06-22
00048503515539Truform®8875WH-XL2026-06-22
00048503515546Truform®8875WH-2L2026-06-22
00048503515553Truform®8875WH-3L2026-06-22
00048503514440Truform®1924BL-S2026-05-05
00048503514471Truform®1924BL-M2026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226440623ViveVIVE HEALTH LLCDWL2026-07-14
00810226440630ViveVIVE HEALTH LLCDWL2026-07-14
00810226440647ViveVIVE HEALTH LLCDWL2026-07-14
00810226440654ViveVIVE HEALTH LLCDWL2026-07-14
00810226440661ViveVIVE HEALTH LLCDWL2026-07-14
00810226440678ViveVIVE HEALTH LLCDWL2026-07-14
00810226440685ViveVIVE HEALTH LLCDWL2026-07-14
00810226440692ViveVIVE HEALTH LLCDWL2026-07-14
00810226440708ViveVIVE HEALTH LLCDWL2026-07-14
00810226440715ViveVIVE HEALTH LLCDWL2026-07-14
00810226440739ViveVIVE HEALTH LLCDWL2026-07-14
00810226440746ViveVIVE HEALTH LLCDWL2026-07-14
00810226440753ViveVIVE HEALTH LLCDWL2026-07-14
00810226440760ViveVIVE HEALTH LLCDWL2026-07-14
00810226440777ViveVIVE HEALTH LLCDWL2026-07-14
00810226440784ViveVIVE HEALTH LLCDWL2026-07-14
00810226440791ViveVIVE HEALTH LLCDWL2026-07-14
00810226440807ViveVIVE HEALTH LLCDWL2026-07-14
00810226440814ViveVIVE HEALTH LLCDWL2026-07-14
00810226440821ViveVIVE HEALTH LLCDWL2026-07-14
00048503515379Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515386Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515393Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515416Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515423Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515430Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515447Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515454Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515461Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22
00048503515478Truform®SURGICAL APPLIANCE INDUSTRIES, INC.DWL2026-06-22