FDA.report

JOBST Elvarex

Primary DI
04019702467475
Brand
JOBST Elvarex
Company
BSN-Jobst GmbH
Model
77565-00415-00
Device description
ELVAREX 3/KNEE HIGH/PROFILE-SLANT-CLOSED TOE/DOTTED SILICONE BAND INSIDE/NAVY
Published
2021-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DWLStocking, medical support (to prevent pooling of blood in legs)

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04019702467475PrimaryGS10

GMDN Terms

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)537-1063BSN.ORDERS@BSNMEDICAL.COM

Regulatory Flags

DUNS number
315917492
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04059993700806JOBST Elvarex Plus79541-00020-0079541-00020-002023-11-18
04059993444939JOBST Confidence73294-00686-0073294-00686-002023-05-02
04059993455676JOBST Confidence73295-00290-0073295-00290-002023-05-02
04059993456338JOBST Confidence73295-00298-0073295-00298-002023-05-02
04059993457564JOBST Confidence73295-00187-0073295-00187-002023-05-02
04059993478156JOBST Confidence73293-00038-0073293-00038-002023-05-02
04059993530618JOBST Confidence73316-00150-0073316-00150-002023-05-02
04059993538416JOBST Confidence73316-00346-0073316-00346-002023-05-02
04059993538607JOBST Confidence73316-00409-0073316-00409-002023-05-02
04059993538645JOBST Confidence73316-00413-0073316-00413-002023-05-02
04059993539499JOBST Confidence73316-00318-0073316-00318-002023-05-02
04059993540594JOBST Confidence73316-00564-0073316-00564-002023-05-02
04059993540730JOBST Confidence73316-00510-0073316-00510-002023-05-02
04059993541133JOBST Confidence73316-00438-0073316-00438-002023-05-02
04059993542109JOBST Confidence73205-00520-0073205-00520-002023-05-02
04059993543342JOBST Confidence73205-00420-0073205-00420-002023-05-02
04059993544677JOBST Confidence73205-00553-0073205-00553-002023-05-02
04059993552054JOBST Confidence73315-00378-0073315-00378-002023-05-02
04059993555406JOBST Confidence73205-00906-0073205-00906-002023-05-02
04059993555895JOBST Confidence73205-00955-0073205-00955-002023-05-02

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