FDA UDI
In Commercial Distribution
🇺🇸 United States
TheraBand Kinesiology Tape
DI: 10087453127406
·
Model: 12740
·
HYGENIC CORPORATION, THE
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- TheraBand Kinesiology Tape
- Primary DI
- 10087453127406
- Version / Model
- 12740
- Company Name
- HYGENIC CORPORATION, THE
- Labeler DUNS
- 004163390
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-03
- Public Version
- 3
- Public Version Date
- 2023-11-22
- Public Version Status
- Update
- Public Device Record Key
- 1fa8db2b-ecfe-4f27-8f75-2a6fb49ae1b5
Device Description
TheraBand Kinesiology Tape, Bulk Roll, 2" x 103.3' - Black/Gray Print, Tape and Bandage, Adhesive
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66337 | Limb immobilization/support skin adhesive tape | A flexible band of fabric, plastic, or other material intended to noninvasively adhere to the skin surface to immobilize a joint and/or support a limb. It may be referred to as sports tape, functional tape, or kinesiology tape and is coated on one side with a pressure-sensitive adhesive and designed with a lower potential for producing an allergic reaction (i.e., hypoallergenic). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30087453127400 | GS1 | Master Carton | 6 | In Commercial Distribution | |
| Primary | 10087453127406 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 2 | Inch | |
| Length | 103.3 | Feet |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dark place