FDA UDI
In Commercial Distribution
🇺🇸 United States
Gentell FixTape (2x11 yards)
DI: 00361554002118
·
Model: GEN-10600
·
Gentell, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
64
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Basic Information
- Brand Name
- Gentell FixTape (2x11 yards)
- Primary DI
- 00361554002118
- Version / Model
- GEN-10600
- Catalog Number
- GEN-10600
- Company Name
- Gentell, LLC
- Labeler DUNS
- 170967876
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 64
- Record Status
- Published
- Publish Date
- 2025-03-26
- Public Version
- 1
- Public Version Date
- 2025-04-03
- Public Version Status
- New
- Public Device Record Key
- e3e2bd51-22d3-484b-94ac-d8afacc9b1f8
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00361554002101 | GS1 | ||||
| Primary | 00361554002118 | GS1 |