FDA UDI
In Commercial Distribution
🇺🇸 United States
Dealmed
DI: 00817415020116
·
Model: 817415020123
·
DEALMED MEDICAL SUPPLIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
12
Basic Information
- Brand Name
- Dealmed
- Primary DI
- 00817415020116
- Version / Model
- 817415020123
- Catalog Number
- 783102
- Company Name
- DEALMED MEDICAL SUPPLIES LLC
- Labeler DUNS
- 068586441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2020-09-11
- Public Version
- 2
- Public Version Date
- 2020-10-02
- Public Version Status
- Update
- Public Device Record Key
- f861fa9e-62b9-46b2-9823-d7890a561718
Device Description
Conforming Stretch Bandage N/S LF Polyester 2" x 4.1 yds 12/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 |
|---|---|---|---|---|
| FQM | BANDAGE, ELASTIC | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58964 | Non-adhesive device retention bandage | A piece or roll of material intended to be wrapped around a part of the body to secure a device (e.g., skin dressing, catheter, cannula) to the patient, without adhering to or compressing the body. It may be made from a variety or combination of materials, including cotton, viscose, and plastic (e.g., polyamide), and some types are cohesive (i.e., the bandage adheres to itself but not to other surfaces); it is used in various clinical specialties (e.g., dermatology, general/plastic surgery). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00817415020123 | GS1 | CASE | 8 | In Commercial Distribution | |
| Primary | 00817415020116 | GS1 | ||||
| Unit of Use | 00817415020017 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2" x 4.1 yds |