FDA UDI
In Commercial Distribution
🇺🇸 United States
DEALMED
DI: 10817415021844
·
Model: 783822
·
DEALMED MEDICAL SUPPLIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- DEALMED
- Primary DI
- 10817415021844
- Version / Model
- 783822
- Catalog Number
- 783822
- Company Name
- DEALMED MEDICAL SUPPLIES LLC
- Labeler DUNS
- 068586441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2021-09-17
- Public Version
- 1
- Public Version Date
- 2021-09-27
- Public Version Status
- New
- Public Device Record Key
- 24f0dea1-4152-4d8e-a58b-ef693cae0934
Device Description
Gauze Sponge Type VII Woven Sterile 2" x 2" 8-Ply 2's 50/Box
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48134 | Woven gauze pad | A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it does not include petrolatum. It is typically used to: clean, cover, or pack wounds or abrasions and absorb their exudates; absorb body-surface exudates; or apply topical medications. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20817415021841 | GS1 | CASE | 30 | In Commercial Distribution | |
| Primary | 10817415021844 | GS1 | ||||
| Unit of Use | 00817415021847 | GS1 |