Tronex International, Inc.
- Primary DI
- 00097604712422
- Brand
- Tronex International, Inc.
- Company
- TRONEX INTERNATIONAL, INC.
- Model
- 7124B
- Device description
- Cap, Bouffant, Spunbond, Fluid Resistant, Latex-Free, Blue, 24"
- 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 Code Classifications
| Code | Device | Specialty | Class |
|---|
| FYF | Cap, Surgical | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10097604712429 | Primary | GS1 | 0 | |
| 00097604712422 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10097604712429 | 10097604712429 | | |
| 00097604712422 | 00097604712422 | 097604712422 | 0097604712422 |
GMDN Terms
| Term | Definition |
|---|
| Surgical hood | A non-sterile head covering designed as a top with elongated sides and back with a front opening for the face to be used by surgical staff to cover their hair and facial hair (beards) in order to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is typically made of soft, disposable materials. This is a single-use device. |
Regulatory Flags
- DUNS number
- 615425519
- Device count
- 500
- 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