FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Performance Health Counter Top Display
DI: 00087453135053
·
Model: 13506
·
HYGENIC CORPORATION, THE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Performance Health Counter Top Display
- Primary DI
- 00087453135053
- Version / Model
- 13506
- Company Name
- HYGENIC CORPORATION, THE
- Labeler DUNS
- 004163390
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-15
- Public Version
- 2
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 6e2fe20f-7fd9-497b-a547-dcced488a1fd
- Distribution End Date
- 2019-07-15
Device Description
TheraBand Kinesiology Tape Precut Roll- Beige/ Beige, TheraBand Kinesiology Tape Precut Roll- Black/ Gray, Hot/Cold Compress, gel and Spray
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 34832 | Waterproof skin adhesive tape | A long and narrow flexible band that is coated on one side with a pressure-sensitive adhesive, and made from a material designed to resist water permeation, intended to be used to cover a surface (e.g., small wound), fix a dressing, attach objects, and/or exert pressure on a body part; it is not hypoallergenic. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00087453135053 | GS1 |