FDA UDI
In Commercial Distribution
🇺🇸 United States
Wood Applicator
DI: 00616784432328
·
Model: 4323
·
Dynarex Corporation
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
864
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Basic Information
- Brand Name
- Wood Applicator
- Primary DI
- 00616784432328
- Version / Model
- 4323
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 864
- Record Status
- Published
- Publish Date
- 2021-09-01
- Public Version
- 3
- Public Version Date
- 2026-03-30
- Public Version Status
- Update
- Public Device Record Key
- da071a57-c634-4b5d-92c6-b9db92e3e3cd
Device Description
Wood Applicator 6"
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
- MR Safe
- 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 |
|---|---|---|---|---|
| KCJ | Applicator, Ent | Ear, Nose, Throat | 874.5220 | 1 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | 880.6025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33722 | General-purpose absorbent tip applicator/swab, single-use | A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00616784432335 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00616784432328 | GS1 | ||||
| Unit of Use | 00810180845175 | GS1 |