FDA UDI
In Commercial Distribution
🇺🇸 United States
NeoSmile™
DI: 10812594013437
·
Model: Hydrogel
·
Neotech Products LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
75
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Basic Information
- Brand Name
- NeoSmile™
- Primary DI
- 10812594013437
- Version / Model
- Hydrogel
- Catalog Number
- N7321
- Company Name
- Neotech Products LLC
- Labeler DUNS
- 198013435
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 75
- Record Status
- Published
- Publish Date
- 2023-09-07
- Public Version
- 2
- Public Version Date
- 2023-09-20
- Public Version Status
- Update
- Public Device Record Key
- b47ef9a9-dac0-44bb-b2f7-93ff0dc7a5bb
Device Description
NeoSmile is intended to cover and secure a temperature probe.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42410 | Electrical cable/lead holder | A device intended to hold medical cables/leads, primarily those that convey electricity and electrical signals. It is typically used in conjunction with an electrocardiograph (ECG) or an electromyograph (EMG) to support and stabilize electrical cable/leads used during patient treatment. It is typically designed as a jointed, adjustable arm with a mounting fixture, that attaches to the recording device, and a holder at the distal end to hold the cables/leads near the patient; it is intended to help organize and protect the cables/leads to prolong their life and help prevent patient disconnection. 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 | 00812594013430 | GS1 | ||||
| Primary | 10812594013437 | GS1 |