FDA UDI
In Commercial Distribution
🇺🇸 United States
Endoring
DI: 00859611006242
·
Model: ERG-S
·
JORDCO INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Endoring
- Primary DI
- 00859611006242
- Version / Model
- ERG-S
- Catalog Number
- ERG-S
- Company Name
- JORDCO INC
- Labeler DUNS
- 803063981
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-08
- Public Version
- 1
- Public Version Date
- 2020-08-17
- Public Version Status
- New
- Public Device Record Key
- fd59b7be-2636-4802-86f1-6e2024193689
Device Description
Endoring Gelwell cups
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- High-level Disinfectant
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIL | Gauge, Depth, Instrument, Dental | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64813 | Endodontic instrument chairside holder set | A collection of devices intended to be used chairside during a endodontic procedure to facilitate the access, handling, temporary storage and convenient selection of endodontic instruments (e.g., files/rasps). The set may be positioned on a surface or worn by the operator (e.g., ring design) and typically includes a plastic housing/rack, disposable spongy foam inserts for holding delicate and sharp rotary endpieces, holders for fluid containers, colour-coded identification labels/tags, and a ruler to help select an appropriate size instrument. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859611006242 | GS1 |