FDA UDI
In Commercial Distribution
🇺🇸 United States
Dale Nasal Dressing Holder
DI: 00817612020827
·
Model: 600
·
DALE MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Dale Nasal Dressing Holder
- Primary DI
- 00817612020827
- Version / Model
- 600
- Catalog Number
- 600
- Company Name
- DALE MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 001061233
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-24
- Public Version
- 1
- Public Version Date
- 2019-07-02
- Public Version Status
- New
- Public Device Record Key
- 34d57dc8-9a34-4ac6-b65d-c8bd932139a0
Device Description
Dale Nasal Dressing Holder, Fits most
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 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 |
|---|---|---|---|---|---|---|
| Previous | H84106001 | HIBCC | ||||
| Package | 00817612020834 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00817612020827 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Cool dry place