Lab Coat
- Primary DI
- 00616784209234
- Brand
- Lab Coat
- Company
- DYNAREX CORPORATION
- Model
- 2092
- Device description
- Lab Coat with Pockets, Knitted Cuffs and Collars, Teal, Small
- Published
- 2021-09-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
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 |
|---|
| 00616784209234 | Package | GS1 | 3 | In Commercial Distribution |
| 00616784209227 | Primary | GS1 | 0 | |
| 00616784209210 | Unit of Use | GS1 | 0 | |
| 00810180843010 | Unit of Use | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Surgical/examination garment kit | A collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device. |
Regulatory Flags
- DUNS number
- 008124539
- Device count
- 10
- 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
- true
- Sterilization required before use
- false
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