FDA UDI
In Commercial Distribution
🇺🇸 United States
5 Piece ClikRay (TM) Kodak Size 2 Holder
DI: 00856200001091
·
Model: 001-091
·
CLIKTECH LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- 5 Piece ClikRay (TM) Kodak Size 2 Holder
- Primary DI
- 00856200001091
- Version / Model
- 001-091
- Catalog Number
- 001-091
- Company Name
- CLIKTECH LLC
- Labeler DUNS
- 044516217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-31
- Public Version
- 1
- Public Version Date
- 2021-01-08
- Public Version Status
- New
- Public Device Record Key
- 9205712a-7d7b-4b8f-bc81-159ca2f0558d
Device Description
5 Piece ClikRay (TM) Kodak Size 2 Holder
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00856200001091 | GS1 | ||||
| Package | 10856200001098 | GS1 | BOX | 16 | In Commercial Distribution |