FDA.reportPublic FDA data

MT Spandage

Primary DI
00027479111150
Brand
MT Spandage
Company
MEDI-TECH INTERNATIONAL CORPORATION
Model
MT11X50
Catalog number
MT11X50
Device description
MT Spandage Tubular Elastic Retainer Net - Size 11 - 50 Yds (stretched)
Published
2019-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQMBandage, Elastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00027479111150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00027479111150000274791111500274791111500027479111150

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-supportive tube/strip, reusableAn 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 reusable 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
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00027479153259SpandaNetteMTSNP15325MTSNP153252019-10-29
00027479131028MT SpandageMT10X24MT10X242019-06-04
00027479131035MT Spandage MT10X36MT10X362019-06-04
00027479131141MT SpandageMT11X24MT11X242019-06-04
00027479131226MT SpandageMT12X24MT12X242019-06-04
00027479131240MT Spandage MT1X24MT1X242019-06-04
00027479132124MT Spandage MT2X12MT2X122019-06-04
00027479132223MT SpandageMT22X24MT22X242019-06-04
00027479132247MT Spandage MT2X24MT2X242019-06-04
00027479133244MT SpandageMT3X24MT3X242019-06-04
00027479133367MT SpandageMT3X36MT3X362019-06-04
00027479134241MT Spandage MT4X24MT4X242019-06-04
00027479134364MT Spandage MT4X36MT4X362019-06-04
00027479135248MT SpandageMT5X24MT5X242019-06-04
00027479135361MT SpandageMT5X36MT5X362019-06-04
00027479136245MT SpandageMT6X24MT6X242019-06-04
00027479136368MT Spandage MT6X36MT6X362019-06-04
00027479137242MT Spandage MT7X24MT7X242019-06-04
00027479137365MT SpandageMT7X36MT7X362019-06-04
00027479138249MT SpandageMT8X24MT8X242019-06-04

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00810178884612ViveCareVIVE HEALTH LLCFQM2026-02-05
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08809302587552Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587569Soosung Elastic Bandagesoosung medicalFQM2025-12-11
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00029369186026McDavidDoctor Shock IncFQM2025-12-01
26975803530802GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530819GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
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30840330705869ProCureTwin Med, LLCFQM2025-11-26
30840330705876ProCureTwin Med, LLCFQM2025-11-26
30840330705883ProCureTwin Med, LLCFQM2025-11-26
04250381827123Head bandageSpiggle & Theis Medizintechnik GmbHFQM2025-09-19
04250381827130Head bandageSpiggle & Theis Medizintechnik GmbHFQM2025-09-19
04250381827147Elastic head bandage with ear slipSpiggle & Theis Medizintechnik GmbHFQM2025-09-19
50192253065280CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15