FDA UDI
In Commercial Distribution
🇺🇸 United States
Plastic for Closed Tray Transfer for Multi-Unit
DI: 07290112444356
·
Model: EI-4765
·
ETGAR - MEDICAL INSTRUMENTS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Plastic for Closed Tray Transfer for Multi-Unit
- Primary DI
- 07290112444356
- Version / Model
- EI-4765
- Company Name
- ETGAR - MEDICAL INSTRUMENTS LTD
- Labeler DUNS
- 514570324
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-04
- Public Version
- 1
- Public Version Date
- 2018-04-04
- Public Version Status
- New
- Public Device Record Key
- 3b9f1e79-c3da-4abf-a90b-efc24f1af3e1
Device Description
Plastic for Closed Tray Transfer for Multi-Unit
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34799 | Composite dental impression material | A thermoplastic material designed to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290112444356 | GS1 |