FDA UDI
In Commercial Distribution
🇺🇸 United States
Tridyne™ Vascular Sealant Extended Spray Tips
DI: 00801741099380
·
Model: TDET0006
·
NEOMEND, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Tridyne™ Vascular Sealant Extended Spray Tips
- Primary DI
- 00801741099380
- Version / Model
- TDET0006
- Catalog Number
- TDET0006
- Company Name
- NEOMEND, INC.
- Labeler DUNS
- 195251595
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-31
- Public Version
- 3
- Public Version Date
- 2021-01-08
- Public Version Status
- Update
- Public Device Record Key
- 01ab6f2b-02a7-4998-8c69-ebe8416e97eb
Device Description
Tridyne Vascular Extended Tips, 6”
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- Yes
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NBE | Sealant,polymerizing | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33722 | General-purpose absorbent tip applicator/swab, single-use | A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741099387 | GS1 | CA | 4 | In Commercial Distribution | |
| Primary | 00801741099380 | GS1 |
Customer Contacts
- Phone
- +1(888)776-4351
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150016 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6 | Inch |