Tronex International, Inc.
- Primary DI
- 00097604573702
- Brand
- Tronex International, Inc.
- Company
- TRONEX INTERNATIONAL, INC.
- Model
- SMS57370W
- Device description
- Coat, Lab, Multilayer, Full Length, Knitted Cuffs, Knitted Collar, Snap Front, W/ Pockets, Fluid Resistant, Latex-Free, White, 8X-Large
- 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 |
|---|
| LYU | Accessory, Surgical Apparel |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10097604573709 | Primary | GS1 | 0 | |
| 00097604573702 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10097604573709 | 10097604573709 | | |
| 00097604573702 | 00097604573702 | 097604573702 | 0097604573702 |
GMDN Terms
| Term | Definition |
|---|
| Professional examination gown, single-use | A garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a single-use garment. |
Regulatory Flags
- DUNS number
- 615425519
- Device count
- 30
- 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