FDA UDI
In Commercial Distribution
🇺🇸 United States
Trinity Sterile, Inc.
DI: 10841767103736
·
Model: 6040
·
Trinity Sterile, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Trinity Sterile, Inc.
- Primary DI
- 10841767103736
- Version / Model
- 6040
- Company Name
- Trinity Sterile, Inc.
- Labeler DUNS
- 154424043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-28
- Public Version
- 2
- Public Version Date
- 2023-12-08
- Public Version Status
- Update
- Public Device Record Key
- af6a643b-8143-4cba-8de0-78cabbac59c4
Device Description
TUBE OCC FCP SM STR 7" STER
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
- 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
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FSM | TRAY, SURGICAL, INSTRUMENT | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13998 | Uterine tenaculum | A hand-held manual surgical instrument with hooks at the distal end used for grasping and/or manipulating uterine tissue during a surgical intervention or examination of the uterus and associated structures (e.g., cervix). It typically has a scissors-like, self-retaining design with ring handles and is made of high-grade stainless steel. It is available in various sizes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00841767103739 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 10841767103736 | GS1 |