FDA UDI
In Commercial Distribution
🇺🇸 United States
AD Surgical
DI: 00814639025675
·
Model: A400-MAYO
·
APPLIED DENTAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- AD Surgical
- Primary DI
- 00814639025675
- Version / Model
- A400-MAYO
- Catalog Number
- A400-MAYO
- Company Name
- APPLIED DENTAL, INC.
- Labeler DUNS
- 017524666
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-18
- Public Version
- 1
- Public Version Date
- 2022-02-28
- Public Version Status
- New
- Public Device Record Key
- c14bd2be-bc67-4ff4-8427-30f2928b0d67
Device Description
Mayo Stand Cover with SMS reinforcement. Disposable. Sterile. 23x55".
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PUI | Drape, Surgical, Exempt | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62934 | Surgical dressing/drape kit, single-use | A collection of various types of patient drapes, dressings, covers and/or towels intended to be used to facilitate a surgical procedure. It does not include any pharmaceuticals, surgical instruments, surgical tubing, or mechanically functional devices and is not dedicated to catheterization support. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10814639025672 | GS1 | box | 10 | In Commercial Distribution | |
| Primary | 00814639025675 | GS1 | ||||
| Package | 20814639025679 | GS1 | Carton | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-888-841-8481
- [email protected]