FDA UDI
In Commercial Distribution
🇺🇸 United States
Kinesio Pre-Cut - Knee
DI: 00850989002263
·
Model: PCK9904
·
Kinesio Holding Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Kinesio Pre-Cut - Knee
- Primary DI
- 00850989002263
- Version / Model
- PCK9904
- Catalog Number
- PCK9904
- Company Name
- Kinesio Holding Corporation
- Labeler DUNS
- 016287801
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-26
- Public Version
- 1
- Public Version Date
- 2023-07-04
- Public Version Status
- New
- Public Device Record Key
- 0e75d2df-5add-4849-8ea2-f93f64e7b33b
Device Description
Elastic Therapeutic Tape / Kinesiology Tape
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
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 34864 | Adhesive bandage | A sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850989002260 | GS1 | Box | 20 | In Commercial Distribution | |
| Primary | 00850989002263 | GS1 | ||||
| Package | 30850989002264 | GS1 | Shipping Box | 500 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(505)856-2029
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 28 | Centimeter | |
| Device Size Text, specify | 28cm (11 inches) | ||
| Device Size Text, specify | 5cm (2 inches) | ||
| Width | 5 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid extreme temperatures.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool dry place.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid direct sunlight.