FDA UDI
In Commercial Distribution
🇺🇸 United States
Nordent Manufacturing, Inc.
DI: 00840018667129
·
Model: RCD918B-919B
·
NORDENT MANUFACTURING INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Nordent Manufacturing, Inc.
- Primary DI
- 00840018667129
- Version / Model
- RCD918B-919B
- Catalog Number
- Nordent Diagnostic Cataloge
- Company Name
- NORDENT MANUFACTURING INC
- Labeler DUNS
- 053187985
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-10
- Public Version
- 1
- Public Version Date
- 2026-02-18
- Public Version Status
- New
- Public Device Record Key
- 6a0cffd6-7f24-43a3-8398-8bfd54708b3e
Device Description
Sinus Lift Special 918-B AND 919-B
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZN | Instruments, Dental Hand | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64303 | Respiratory oxygen therapy pulse oximeter-regulator interface | An electrically-powered device designed to interface between a pulse oximeter probe and an electronic medical gas regulating unit during oxygen (O2) therapy, to continuously monitor haemoglobin oxygen saturation (SpO2), calculate the appropriate volume of O2 needed to be delivered to the patient based on SpO2 values, and transmit an electronic signal to the electronic O2 regulating unit. It includes a display, alarm(s), and integrated software; it does not come into direct contact with medical gases (i.e., does not include a gas regulator or tubing). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840018667129 | GS1 |
Customer Contacts
- Phone
- 8474374780
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6.5 | Inch |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 40 – 60 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 350 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 65 – 75 Degrees Fahrenheit