FDA UDI
In Commercial Distribution
🇺🇸 United States
Dealmed
DI: 00817415020505
·
Model: 817415020673
·
DEALMED MEDICAL SUPPLIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
Basic Information
- Brand Name
- Dealmed
- Primary DI
- 00817415020505
- Version / Model
- 817415020673
- Catalog Number
- 783042
- Company Name
- DEALMED MEDICAL SUPPLIES LLC
- Labeler DUNS
- 068586441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2020-09-11
- Public Version
- 4
- Public Version Date
- 2022-12-20
- Public Version Status
- Update
- Public Device Record Key
- e28539a7-46ec-4173-aef7-a07f400880f2
Device Description
Gauze Sponge Woven N/S 4" x 4" 8-Ply 200/Box
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| NAB | Gauze / sponge,nonresorbable for external use | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48128 | Gauze strip, non-antimicrobial | A thin length of non-medicated woven material (e.g., cotton, cellulose) primarily designed to pack draining wounds to absorb exudates; it does not include an antimicrobial agent. It may be soaked with medication (not included) before application. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00817415020673 | GS1 | CASE | 20 | In Commercial Distribution | |
| Primary | 00817415020505 | GS1 | ||||
| Unit of Use | 10817415020502 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 4" x 4" |