FDA UDI
In Commercial Distribution
🇺🇸 United States
CARDINAL HEALTH ESSENTIALS
DI: 00885380122692
·
Model: ZTCL02A
·
RGH ENTERPRISES
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
6
Basic Information
- Brand Name
- CARDINAL HEALTH ESSENTIALS
- Primary DI
- 00885380122692
- Version / Model
- ZTCL02A
- Catalog Number
- ZTCL02A
- Company Name
- RGH ENTERPRISES
- Labeler DUNS
- 049735438
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2019-05-22
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 0e19f804-e2f4-45b3-8f67-350481e004e7
Device Description
Cloth Surgical Tape; 2 in. x 10 yd; Water resistant; Breathable; Serrated edges to aid tearing
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
- 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 |
|---|---|---|---|---|
| 16866 | Dressing-fixation skin adhesive tape, non-silicone | A long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885380122697 | GS1 | CASE | 24 | In Commercial Distribution | |
| Primary | 00885380122692 | GS1 | ||||
| Unit of Use | 10885380122699 | GS1 |
Customer Contacts
- Phone
- +1(800)409-2848
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10 | Yard | |
| Height | 2 | Inch |