FDA UDI
In Commercial Distribution
🇺🇸 United States
Dealmed
DI: 00817415020017
·
Model: 783112
·
DEALMED MEDICAL SUPPLIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
12
Basic Information
- Brand Name
- Dealmed
- Primary DI
- 00817415020017
- Version / Model
- 783112
- Catalog Number
- 783112
- Company Name
- DEALMED MEDICAL SUPPLIES LLC
- Labeler DUNS
- 068586441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2020-11-24
- Public Version
- 2
- Public Version Date
- 2022-02-21
- Public Version Status
- Update
- Public Device Record Key
- 4c40cabb-3a1d-44d4-9782-6371c4fd6874
Device Description
Conforming Stretch Bandage Sterile LF 2" x 4.1 yds, 12/Bx
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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FQM | BANDAGE, ELASTIC | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47011 | First aid absorbent pad/bandage | A wound cover intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00817415020048 | GS1 | CASE | 8 | In Commercial Distribution | |
| Primary | 00817415020017 | GS1 | ||||
| Unit of Use | 00817415020833 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2" x 4.1 yds |