FDA UDI
In Commercial Distribution
🇺🇸 United States
Darby Dental Supply, LLC
DI: 00889813060148
·
Model: 5255426
·
DARBY DENTAL SUPPLY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Darby Dental Supply, LLC
- Primary DI
- 00889813060148
- Version / Model
- 5255426
- Catalog Number
- 5255426
- Company Name
- DARBY DENTAL SUPPLY, LLC
- Labeler DUNS
- 825137818
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2023-07-22
- Public Version
- 1
- Public Version Date
- 2023-07-31
- Public Version Status
- New
- Public Device Record Key
- 68c94f1b-ddc5-497b-877b-d78cd35f8ce2
Device Description
SALIVA ABSORBENTS LARGE ESA-L
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
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KHR | ABSORBER, SALIVA, PAPER | Dental | 872.6050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33531 | Saliva absorbent | A non-sterile device designed to absorb moisture from the oral cavity during a dental procedure. Also known as a saliva absorber, it can be in a variety of shapes and sizes and is typically made of paper, cotton, or polymeric web, and may have a high-absorbent core. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10889813060145 | GS1 | ||||
| Primary | 00889813060148 | GS1 |