FDA UDI
In Commercial Distribution
🇺🇸 United States
Lab Coats Knitted Cuffs & Collar Without Pockets, XX-Large, White
DI: 00616784198620
·
Model: 1986
·
Dynarex Corporation
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
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Basic Information
- Brand Name
- Lab Coats Knitted Cuffs & Collar Without Pockets, XX-Large, White
- Primary DI
- 00616784198620
- Version / Model
- 1986
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-04-17
- Public Version
- 4
- Public Version Date
- 2026-02-20
- Public Version Status
- Update
- Public Device Record Key
- 4e34c90b-e41b-4401-8134-c503e0699ab2
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OEA | Non-Surgical Isolation Gown | General, Plastic Surgery | 878.4040 | 1 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | 878.4040 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61938 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00616784198637 | GS1 | Case | 3 | In Commercial Distribution | |
| Primary | 00616784198620 | GS1 | ||||
| Unit of Use | 00810180842761 | GS1 |