FDA.reportPublic FDA data

Spanda-Sleeves

Primary DI
00027479202667
Brand
Spanda-Sleeves
Company
MEDI-TECH INTERNATIONAL CORPORATION
Model
MTPS26001
Catalog number
MTPS26001
Device description
Spanda-Sleeves Leg Sleeve - Size Medium - Size Color Code: Green - Light Skin Tone
Published
2019-07-23
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
00027479202667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00027479202667000274792026670274792026670027479202667

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-supportive tube/strip, single-useAn elastic device intended to be worn over/around a limb (arm/leg) and/or finger to cover and support a dressing on a wound/injury (e.g., burn, postoperative, skin condition). It may be referred to as a dressing/bandage retainer and is either in the form of a generic tube (i.e., not a specific garment such as a sock, glove, vest, shorts, or hat) or gripping elastic strip made of synthetic material (e.g., nylon/elastane), and is available in various sizes for daily use in the home or healthcare facility. It may additionally be intended for use at other anatomical sites (where size is appropriate) however it is not dedicated to the abdomen/thorax. 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
00027479134258SpandaNetteMTSN13425MTSN134252019-10-29
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

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