Tronex International, Inc.
- Primary DI
- 00097604761024
- Brand
- Tronex International, Inc.
- Company
- TRONEX INTERNATIONAL, INC.
- Model
- 7610B
- Device description
- Cover, Shoe, Spunbond, Heavy-Weight, Non-Skid, Fluid Resistant, Latex-Free, Blue, Unisize
- Published
- 2022-10-28
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| FXP | Cover, Shoe, Operating-Room |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FXP | Cover, Shoe, Operating-Room | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10097604761021 | Primary | GS1 | 0 | |
| 00097604761024 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10097604761021 | 10097604761021 | | |
| 00097604761024 | 00097604761024 | 097604761024 | 0097604761024 |
GMDN Terms
| Term | Definition |
|---|
| Shoe cover | A loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device. |
Regulatory Flags
- DUNS number
- 615425519
- Device count
- 300
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00097604555517 | Tronex International, Inc. | 5555W | | 2025-07-28 |
| 00097604577021 | Tronex International, Inc. | 577025W | | 2025-07-24 |
| 00097604577045 | Tronex International, Inc. | 577035W | | 2025-07-24 |
| 00097604130585 | Tronex International, Inc. | TCB0305C | | 2025-05-01 |
| 00097604140584 | Tronex International, Inc. | TCB0405C | | 2025-05-01 |
| 00097604160582 | Tronex International, Inc. | TCB0605C | | 2025-05-01 |
| 00097604220583 | Tronex International, Inc. | TLB2205L | | 2025-05-01 |
| 00097604330589 | Tronex International, Inc. | TLB3305L | | 2025-05-01 |
| 00097604440585 | Tronex International, Inc. | TLB4405L | | 2025-05-01 |
| 00097604660587 | Tronex International, Inc. | TLB6605L | | 2025-05-01 |
| 00097604015561 | Tronex International, Inc. | TCB0155R | | 2025-01-28 |
| 00097604010580 | Tronex International, Inc. | TCB0105C | | 2024-12-30 |
| 00097604020589 | Tronex International, Inc. | TCB0205C | | 2024-12-30 |
| 00097604110587 | Tronex International, Inc. | TCB1105A | | 2024-12-30 |
| 00097604120586 | Tronex International, Inc. | TCB1205A | | 2024-12-30 |
| 00097604212199 | Tronex International, Inc. | SD2121 | | 2024-12-30 |
| 00097604215190 | Tronex International, Inc. | SD2151 | | 2024-12-30 |
| 00097604313193 | Tronex International, Inc. | SD3131 | | 2024-12-30 |
| 00097604422291 | Tronex International, Inc. | TCB4222N | | 2024-12-30 |
| 00097604423397 | Tronex International, Inc. | TCB4233N | | 2024-12-30 |
Other Devices Sharing Product Codes