FDA UDI
In Commercial Distribution
🇺🇸 United States
Elite Transparent Tape
DI: 00816703023044
·
Model: ELITE-15010
·
MEDSOURCE INTERNATIONAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Elite Transparent Tape
- Primary DI
- 00816703023044
- Version / Model
- ELITE-15010
- Catalog Number
- Not Applicable
- Company Name
- MEDSOURCE INTERNATIONAL LLC
- Labeler DUNS
- 041674552
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-19
- Public Version
- 4
- Public Version Date
- 2022-11-29
- Public Version Status
- Update
- Public Device Record Key
- 580d5191-ebb2-4c73-9d08-89626fe3cf8f
Device Description
Elite, Transparent Tape, 1 / Elite First Aid Part Number: 4014
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00816703023044 | GS1 | ||||
| Package | 00816703023051 | GS1 | Case | 12 | In Commercial Distribution |