FDA UDI
In Commercial Distribution
🇺🇸 United States
Trinity Sterile, Inc.
DI: 10841767106201
·
Model: 1200SM
·
Trinity Sterile, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Trinity Sterile, Inc.
- Primary DI
- 10841767106201
- Version / Model
- 1200SM
- Company Name
- Trinity Sterile, Inc.
- Labeler DUNS
- 154424043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-01
- Public Version
- 2
- Public Version Date
- 2023-10-20
- Public Version Status
- Update
- Public Device Record Key
- ca82c025-ac9b-4c64-b9df-494142914652
Device Description
FINGER TOURNIQUET SMALL
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
- MR Unsafe
- 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
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAX | TOURNIQUET, NONPNEUMATIC | General, Plastic Surgery | 878.5900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52827 | Schistosoma mansoni total antibody IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to the parasitic flatworm Schistosoma mansoni in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40841767106202 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 10841767106201 | GS1 |