FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Assured
DI: 00639277526489
·
Model: 275152
·
Dollar Tree Mdsg Chesapeake Ci
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Assured
- Primary DI
- 00639277526489
- Version / Model
- 275152
- Company Name
- Dollar Tree Mdsg Chesapeake Ci
- Labeler DUNS
- 610322518
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-05-29
- Public Version
- 3
- Public Version Date
- 2021-08-24
- Public Version Status
- Update
- Public Device Record Key
- 97ed904c-24c4-476a-ac3e-60ae57c34d08
- Distribution End Date
- 2021-07-24
Device Description
Non-Stick Pads, 2 in x 3 in (5 cm x 7.6 cm)
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
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | 878.4018 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48131 | Non-woven gauze pad | A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20639277526483 | GS1 | case | 24 | Not in Commercial Distribution | 2021-07-24 |
| Primary | 00639277526489 | GS1 | ||||
| Unit of Use | 60639277526481 | GS1 |