FDA UDI
In Commercial Distribution
🇺🇸 United States
Trinity Sterile, Inc.
DI: 10841767102982
·
Model: 20321
·
Trinity Sterile, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Trinity Sterile, Inc.
- Primary DI
- 10841767102982
- Version / Model
- 20321
- Company Name
- Trinity Sterile, Inc.
- Labeler DUNS
- 154424043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-04
- Public Version
- 1
- Public Version Date
- 2023-10-12
- Public Version Status
- New
- Public Device Record Key
- 782fd893-9aab-4740-ab24-bbe8b24762e9
Device Description
INCISION & DRAINAGE TRAY
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35118 | Incision/drainage kit | A non-dedicated collection of sterile devices designed to create an opening in the body and place a drain. It typically includes a scalpel and tubes used for this purpose. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00841767102985 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 10841767102982 | GS1 |