FDA.reportPublic FDA data

SpandaNette

Primary DI
00027479134258
Brand
SpandaNette
Company
MEDI-TECH INTERNATIONAL CORPORATION
Model
MTSN13425
Catalog number
MTSN13425
Device description
SpandaNette Tubular Cotton Stockinette Single Ply - Natural - Size 4 - Non-Sterile
Published
2019-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00027479134258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00027479134258000274791342580274791342580027479134258

GMDN Terms#

Term, Definition table
TermDefinition
StockinetteA knitted, seamless, expandable tubing, typically made of cotton, that is open at both ends and intended to be used to hold bandages in place; to place uniform pressure on a leg, finger, arm, or other part of an extremity; to pad the area under a cast or splint; or to cover a stump when a prosthesis is worn. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
414-570-8880Marilyn.Geiger@medi-techintl.com

Regulatory Flags#

DUNS number
063865158
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00027479153259SpandaNetteMTSNP15325MTSNP153252019-10-29
00027479132254SpandaNette MTSN13225MTSN132252019-10-29
00027479135255SpandaNette MTSN13525MTSN135252019-10-29
00027479131059SpandaNetteMTSN131025MTSN1310252019-10-29
00027479131257SpandaNetteMTSN31225MTSN312252019-10-29
00027479131455SpandaNetteMTSN131425MTSN1314252019-10-29
00027479133251SpandaNette MTSN13325MTSN133252019-10-29
00027479136252SpandaNette MTSN13625MTSN136252019-10-29
00027479138256SpandaNetteMTSN13825MTSN138252019-10-29
00027479152252SpandaNetteMTSNP15225MTSNP152252019-10-29
00027479142505SpandaNette MTSNB14250MTSNB142502019-09-11
00027479143502SpandaNette MTSNB14350MTSNB143502019-09-11
00027479144509SpandaNette MTSNB14450MTSNB144502019-09-11
00027479145506SpandaNette MTSNB14550MTSNB145502019-09-11
00027479146503SpandaNetteMTSNB14650MTSNB146502019-09-11
00027479148507SpandaNetteMTSNB14850MTSNB148502019-09-11
00027479151057SpandaNetteMTSNP151025MTSNP1510252019-09-11
00027479151255SpandaNetteMTSNP151225MTSNP1512252019-09-11
00027479151453SpandaNette MTSNP151425MTSNP1514252019-09-11
00027479154256SpandaNette MTSNP15425MTSNP154252019-09-11

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Primary DI, Brand, Company table
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00609271009103DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
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00609271166141DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
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00609271166165DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166172DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08