FDA UDI
In Commercial Distribution
🇺🇸 United States
Tridyne
DI: 00801741099366
·
Model: TDVS004
·
NEOMEND, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Tridyne
- Primary DI
- 00801741099366
- Version / Model
- TDVS004
- Catalog Number
- TDVS004
- 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
- 6
- Public Version Date
- 2025-08-01
- Public Version Status
- Update
- Public Device Record Key
- 5d81d919-c4a7-4937-8ba8-9fad157e6221
Device Description
Tridyne, Vascular Sealant, Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 60777 | Surgical internal adhesive/sealant, human-derived | A bioabsorbable substance containing human-derived material [e.g., human serum albumin (HSA)] intended to be used for internal surgical applications to bond or seal cut, incised, or resected body tissues typically as an adjunct to standard methods of closure, to seal leaks, and might in addition be intended to achieve haemostasis through tissue sealing. Disposable mixing devices/applicators may be included for preparation and application to anatomical sites. After application, this device cannot be reused. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741099363 | GS1 | CA | 4 | In Commercial Distribution | |
| Primary | 00801741099366 | GS1 |
Customer Contacts
- Phone
- +1(888)776-4351
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 4 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius