FDA UDI
In Commercial Distribution
🇺🇸 United States
Wound Management Tray, Sterile
DI: 00840117333598
·
Model: 3092
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Wound Management Tray, Sterile
- Primary DI
- 00840117333598
- Version / Model
- 3092
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-18
- Public Version
- 2
- Public Version Date
- 2024-10-09
- Public Version Status
- Update
- Public Device Record Key
- f9d4cc83-873f-4484-b5eb-6826842a7233
Device Description
Contents: 1 Tray, 25 Non-woven gauze pads, 2 Cotton tip applicators, 1 Tongue depressor, 1 Bag with twist tie, 1 Towel drape. Sterile EO.
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62744 | Wound dressing kit, non-medicated | A collection of instruments and dressings intended to be used to dress a wound. Items typically include scissors, forceps, gauze, and cotton-tip applicators; it does not contain a pharmaceutical. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840117333598 | GS1 | ||||
| Package | 00840117333574 | GS1 | MC | 20 | In Commercial Distribution |