FDA.reportPublic FDA data

Maxtaping

Primary DI
08402706000865
Brand
Maxtaping
Company
Oppo Medical Inc.
Model
8194-RD-F
Catalog number
8194
Device description
Maxtaping, 50mm Width x 4m Length/ 6 Rolls
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KOXSolvent, Adhesive Tape

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOXSolvent, Adhesive TapeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08402706027664PrimaryGS10
08402706000865Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08402706027664084027060276648402706027664
08402706000865084027060008658402706000865

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, non-latex, single-useA strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width50Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Please store at room temperature. Avoid sunlight and/or exposure to excessive heat or moisture.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
830140807
Device count
6
DM exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840270610062Maxtaping8007-BU-F80072025-04-01
00840270610369Maxtaping8080-BU-F80802025-04-01
00840270610512Maxtaping8007-BU-F80072025-04-01
00840270610529Maxtaping8080-BU-F80802025-04-01
00840270627466Maxtaping A+8095-BG-S80952022-12-01
00840270627473Maxtaping A+8095-BG-M80952022-12-01
00840270627480Maxtaping A+8095-BG-L80952022-12-01
00840270627497Maxtaping A+8095-PK-S80952022-12-01
00840270627503Maxtaping A+8095-PK-M80952022-12-01
00840270627510Maxtaping A+8095-PK-L80952022-12-01
00840270627527Maxtaping A+8095-BU-S80952022-12-01
00840270627534Maxtaping A+8095-BU-M80952022-12-01
00840270627541Maxtaping A+8095-BU-L80952022-12-01
00840270627626Maxtaping8194-BG-F81942022-12-01
00840270627633Maxtaping8194-BK-F81942022-12-01
00840270627640Maxtaping8194-BU-F81942022-12-01
00840270627657Maxtaping8194-YW-F81942022-12-01
00840270627664Maxtaping8194-RD-F81942022-12-01
00840270627671Maxtaping A+8195-BG-S81952022-12-01
00840270627688Maxtaping A+8195-BG-M81952022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30197344179811MEDLINEMEDLINE INDUSTRIES, INC.KOX2026-05-15
08904428744992OSSEOUS-Cleaning PadEON MEDITECH PRIVATE LIMITEDKOX2026-03-13
08904428745012OSSEOUS- Adhesion Remover PadEON MEDITECH PRIVATE LIMITEDKOX2026-03-13
08904428798469OSSEOUS-Cleaning PadEON MEDITECH PRIVATE LIMITEDKOX2026-03-13
08904428799749OSSEOUS- Adhesion Remover PadEON MEDITECH PRIVATE LIMITEDKOX2026-03-13
307073877738793M™3M COMPANYKOX2026-02-19
007073875674603M™3M COMPANYKOX2026-02-19
507073875674653M™3M COMPANYKOX2026-02-19
507073877738733M™3M COMPANYKOX2026-02-19
30080196771763MEDLINEMEDLINE INDUSTRIES, INC.KOX2025-05-07
40080196771760MEDLINEMEDLINE INDUSTRIES, INC.KOX2025-05-07
00840270610062MaxtapingOppo Medical Inc.KOX2025-04-01
00840270610369MaxtapingOppo Medical Inc.KOX2025-04-01
00840270610512MaxtapingOppo Medical Inc.KOX2025-04-01
00840270610529MaxtapingOppo Medical Inc.KOX2025-04-01
06950715505625cofoeCofoe Medical Technology Co.,LtdKOX2024-12-09
00810113577784ViveCareVIVE HEALTH LLCKOX2024-09-04
00810113577791ViveCareVIVE HEALTH LLCKOX2024-09-04
10810113577781ViveCareVIVE HEALTH LLCKOX2024-09-04
10810113577798ViveCareVIVE HEALTH LLCKOX2024-09-04
10193489131550MEDLINEMEDLINE INDUSTRIES, INC.KOX2024-07-04
20193489131557MEDLINEMEDLINE INDUSTRIES, INC.KOX2024-07-04
00810049490676Skinister MedicalDelta Molding LLCKOX2024-05-14
00810049490706Skinister MedicalDelta Molding LLCKOX2024-05-14
10884521738362ANS MEDICALCardinal Health, Inc.KOX2023-05-17
60884521738367ANS MEDICALCardinal Health, Inc.KOX2023-05-17
00850048477063WarriorNPWarriornp LLCKOX2023-03-03
00815991024771BodyMedBOXOUT, LLCKOX2023-02-17
00749756877978DeRoyalDEROYAL INDUSTRIES, INC.KOX2023-02-02
00749756877985DeRoyalDEROYAL INDUSTRIES, INC.KOX2023-02-02