FDA UDI
In Commercial Distribution
🇺🇸 United States
Steri-Shield
DI: 10850040097235
·
Model: 088-040
·
Steri-Shield Products
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
18
Basic Information
- Brand Name
- Steri-Shield
- Primary DI
- 10850040097235
- Version / Model
- 088-040
- Company Name
- Steri-Shield Products
- Labeler DUNS
- 026709913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 18
- Record Status
- Published
- Publish Date
- 2022-06-03
- Public Version
- 1
- Public Version Date
- 2022-06-13
- Public Version Status
- New
- Public Device Record Key
- 94fdc1b5-8276-4d80-805d-325e6bdb8898
Device Description
Anterior Bar - Case
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EGZ | Holder, Film, X-Ray | Dental | 872.1905 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16205 | Dental x-ray film holder, reusable | A device designed to hold x-ray film while a dental x-ray is being taken and that enables insertion, positioning, stabilization, and removal of the x-ray film for either extraoral or intraoral dental imaging procedures. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00850040097238 | GS1 | ||||
| Primary | 10850040097235 | GS1 |