FDA UDI
In Commercial Distribution
🇺🇸 United States
Quala
DI: D023WEADCESI3
·
Model: WEADCESI
·
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Quala
- Primary DI
- D023WEADCESI3
- Version / Model
- WEADCESI
- Catalog Number
- WEADCESI
- Company Name
- NATIONAL DISTRIBUTION & CONTRACTING, INC.
- Labeler DUNS
- 009831413
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-27
- Public Version
- 1
- Public Version Date
- 2022-10-05
- Public Version Status
- New
- Public Device Record Key
- 5ffd8b6b-c9cb-49f8-943f-faed237a7581
Device Description
QUALA TOWEL 2PLY PAPER W/POLY ECONOBK 19X13 SIL GREY 500/CS
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 |
|---|---|---|---|---|
| 61048 | Patient examination/treatment drape, single-use | A non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during an examination or non-surgical treatment procedure in the home or healthcare facility primarily to prevent soiling/cross-contamination; it is not intended for surgical use. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D023WEADCESI3 | HIBCC |