FDA.reportPublic FDA data

Truform®

Primary DI
00048503511616
Brand
Truform®
Company
SURGICAL APPLIANCE INDUSTRIES, INC.
Model
NV1165BG-S
Published
2024-12-06
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
00048503511616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00048503511616000485035116160485035116160048503511616

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.

Sterilization Methods#

Method table
Method

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
00048503514440Truform®1924BL-S2026-05-05
00048503514471Truform®1924BL-M2026-05-05
00048503514488Truform®1924BL-L2026-05-05
00048503514495Truform®1924BL-XL2026-05-05
00048503514501Truform®1924BN-S2026-05-05
00048503514518Truform®1924BN-M2026-05-05
00048503514549Truform®1924BN-L2026-05-05
00048503514570Truform®1924BN-XL2026-05-05
00048503514594Truform®1924CH-S2026-05-05
00048503514617Truform®1924CH-M2026-05-05
00048503514648Truform®1924CH-L2026-05-05
00048503514679Truform®1924CH-XL2026-05-05
00048503514693Truform®1924NV-S2026-05-05
00048503514709Truform®1924NV-M2026-05-05
00048503514716Truform®1924NV-L2026-05-05
00048503514747Truform®1924NV-XL2026-05-05
00048503514778Truform®1924TN-S2026-05-05
00048503514785Truform®1924TN-M2026-05-05
00048503514792Truform®1924TN-L2026-05-05
00048503514846Truform®1924TN-XL2026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253015980T.E.D.Cardinal Health 200, LLCDWL2026-05-20
08300496042921SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496042938SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496042945SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496042952SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496042969SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496042976SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496053767SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496053774SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496053781SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496062585SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496063667SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
08300496067535SOLIDEACALZIFICIO PINELLI SRLDWL2025-10-31
10192253015881T.E.D.Cardinal Health 200, LLCDWL2024-09-24
10192253015904T.E.D.Cardinal Health 200, LLCDWL2024-09-24
10192253015911T.E.D.Cardinal Health 200, LLCDWL2024-09-24
10192253015928T.E.D.Cardinal Health 200, LLCDWL2024-09-24
10192253015591T.E.D.Cardinal Health 200, LLCDWL2024-06-10
10612479266954McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479266978McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479266992McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267012McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267036McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267050McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267074McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267098McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267111McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267135McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267159McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16
10612479267173McKessonMCKESSON MEDICAL-SURGICAL INC.DWL2023-07-16