FDA.reportPublic FDA data

New Balance

Primary DI
20888625001619
Brand
New Balance
Company
RENFRO CORPORATION
Model
N915 Black Large
Device description
Graduated Compression Support Sock Firm Support (20-30 mmHg) Over the Calf, Closed Toe
Published
2016-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123398000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123398000DR. SCHOLL'S COMPRESSION SOCKSRenfro Corporation2012-12-18DWL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888625001619PackageGS16In Commercial Distribution
00888625001615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088862500161920888625001619
00888625001615008886250016158886250016150888625001615

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 normally available [non-prescription] over-the-counter (OTC) for use in the home and/or for hospitalized patients. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
865-655-8134callcenter@renfro.com

Regulatory Flags#

DUNS number
003219318
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00042825634022Dr. Scholl'sDSL-7120-BL1-SK2017-08-08
00042825634039Dr. Scholl'sDSM-7000-BXL1-SK2017-08-08
00042825634046Dr Scholl'sDSM-7000-BL1-SK2017-08-08
00042825634053Dr. Scholl'sDSL-7110-BGL1-SK Beige Large2016-09-30
00888625001608New BalanceN915 Black Medium2016-11-08
00888625001615New BalanceN915 Black Large 2016-11-08
00888625001622New BalanceN915 White Medium2016-11-08
00888625001639New BalanceN915 White Large2016-09-30
00888625011393New BalanceN915 Black X-Large 2016-09-30
00888625011409New BalanceN915 White X-Large2016-11-08
00042825534841Dr Scholl'sDSL-7110-BGL1 Beige Large2016-09-30
20042825634057Dr. Scholl'sDSL-7110-BGL1-SK Beige Large2016-09-30
20888625001602New BalanceN915 Black Medium2016-11-08
20888625001626New BalanceN915 White Medium2016-11-08
20888625001633New BalanceN915 White Large2016-09-30
20888625011397New BalanceN915 Black X-Large 2016-09-30
20888625011403New BalanceN915 White X-Large2016-11-08
20042825634026Dr. Scholl'sDSL-7120-BL1-SK2017-08-08
20042825634033Dr. Scholl'sDSM-7000-BXL1-SK2017-08-08
20042825634040Dr Scholl'sDSM-7000-BL1-SK2017-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4200211Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4200221Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201021Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201031Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201041Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4201061Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4202011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4202021Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203001Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203011Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203021Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203031Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203041Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203051Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203061Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203071Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203081Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203091Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203311Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203321Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203331Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203341Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203351Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203361Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203371Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203381Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203391Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203411Compression StockingGottfried Medical, Inc.DWL2026-06-04
G4203421Compression StockingGottfried Medical, Inc.DWL2026-06-04