FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposa-Shield®
DI: D003A8801051
·
Model: A880105
·
Dentsply Professional
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
150
Basic Information
- Brand Name
- Disposa-Shield®
- Primary DI
- D003A8801051
- Version / Model
- A880105
- Company Name
- Dentsply Professional
- Labeler DUNS
- 144140845
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 150
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 4388d286-8e48-4967-9637-25e3ba62d942
Device Description
Disposa-Shield® Disposable Barrier For Universal Chair Back/X-Ray Head. Box of 150
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| EFB | HANDPIECE, AIR-POWERED, DENTAL | Dental | 872.4200 | 1 |
| PEM | Dental barriers and sleeves | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33878 | Cable/lead/sensor/probe cover, non-sterile | A non-sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier to protect the contents from soiling and contamination so that the non-sterile contents may be used in the vicinity of, or enter into a hygienic area, e.g., a sterile surgical field. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D003A8801052 | HIBCC | Case | 5 | In Commercial Distribution | |
| Primary | D003A8801051 | HIBCC | ||||
| Unit of Use | D003A8801050 | HIBCC |
Customer Contacts
- Phone
- +1(800)989-8825
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from rain.
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius