FDA.reportPublic FDA data

SpandaGrip

Primary DI
00027479193194
Brand
SpandaGrip
Company
MEDI-TECH INTERNATIONAL CORPORATION
Model
SAG13119
Catalog number
SAG13119
Device description
SpandaGrip Tubular Elastic Support Bandage - Size (L) 13 IN x11 Yds - Natural
Published
2019-07-01
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
HMWDrape, Microscope, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMWDrape, Microscope, OphthalmicGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00027479193194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00027479193194000274791931940274791931940027479193194

GMDN Terms#

Term, Definition table
TermDefinition
Tubular support bandage, non-latex, reusableA tubular, elastic fabric (e.g., polyamide, Lycra) sleeve intended to be externally worn on a limb to provide support or local pressure to a part of the body, especially a joint, for various preventative/therapeutic applications (e.g., support soft tissue injuries) while enabling movement. Sometimes referred to as a tubigrip, it may be designed to accommodate one or more anatomies (e.g., ankles, knees, wrists). It is not designed specifically to apply an even or graduated force to the limb (i.e., not a compression/pressure garment). This is a single-patient, 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810123208616Adler Instrument CompanyAdler, Inc.HMW2025-02-18
00810123208135Adler Instrument CompanyAdler, Inc.HMW2024-12-13
00840277124739Innomed, Inc.INNOMED, INC.HMW2020-01-31
04048438005170n.a.Karl Storz GmbH & Co. KGHMW2018-08-21
00852205007892Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.HMW2017-10-24
00852205007922Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.HMW2017-10-24
00852205007915Exact Medical ManufacturingEXACT MEDICAL MANUFACTURING, INC.HMW2017-10-24
00852205007946Exact Medical ManufacturingEXACT MEDICAL MANUFACTURING, INC.HMW2017-10-24
10885403067532V. MuellerCAREFUSION 2200, INCHMW2017-10-17
10885403133893V. MuellerCAREFUSION 2200, INCHMW2017-10-17
10885403067600V. MuellerCAREFUSION 2200, INCHMW2017-10-17
20885403067539V. MuellerCAREFUSION 2200, INCHMW2017-10-17
20885403133890V. MuellerCAREFUSION 2200, INCHMW2017-10-17
00190769003555Vashe Sterile SleeveURGO MEDICAL NORTH AMERICA, LLCHMW2017-07-17
10190769003552Vashe Sterile SleeveURGO MEDICAL NORTH AMERICA, LLCHMW2017-07-17
04049539103536Sterilizable Metal SleeveCarl Zeiss Meditec AGHMW2017-05-04
040495391024542-Pack Asepsis VISULUXCarl Zeiss Meditec AGHMW2017-05-04
04049539103284Sterilizable Metal SleeveCarl Zeiss Meditec AGHMW2017-05-04
00815384021004OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021035OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021066OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021097OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021127OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021158OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021189OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021240OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021271OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021301OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021332OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24
00815384021363OPTICS ONEMEDICAL TECHNIQUE, INC.HMW2016-09-24