FDA UDI
In Commercial Distribution
🇺🇸 United States
Philips Zoom
DI: 00075020044129
·
Model: DIS716/01
·
Discus Dental, LLC
Product Codes
3
GMDN Terms
3
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Philips Zoom
- Primary DI
- 00075020044129
- Version / Model
- DIS716/01
- Company Name
- Discus Dental, LLC
- Labeler DUNS
- 831726109
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-28
- Public Version
- 4
- Public Version Date
- 2024-02-01
- Public Version Status
- Update
- Public Device Record Key
- 1809ed2a-0e98-4016-a0a5-4d7bacd2e87b
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EIE | DAM, RUBBER | Dental | 872.6300 | 1 |
| EIF | ACCESSORIES, RETRACTOR, DENTAL | Dental | 872.4565 | 1 |
| EFN | COTTON, ROLL | Dental | 872.6050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57964 | Gingiva bleaching protector | A non-sterile paste or gel-like substance designed to protect a patient's gums from the hydrogen peroxide (H2O2) found in teeth whitening agents used during chairside light-curing bleaching of the teeth. It is typically supplied in a disposable syringe and is applied with an applicator along the gingiva leaving the teeth exposed for treatment. After application, this device cannot be reused. | No | Active |
| 63315 | Dental cheek retractor, professional, single-use | A hands-free, self-retaining frame intended to allow a dental professional to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure for easy access to the field of operation. It is designed to be placed in and around the lips/cheeks and may also be designed to displace the tongue. It is a synthetic polymer device which may include suction adaptors/tubing for saliva removal to maintain a dry field. It is not intended to be placed between the teeth (i.e., not a mouth gag). This is a single-use device. | No | Active |
| 31815 | Dental cotton roll | A non-sterile designed as an absorbent, non-sterile mass of cotton or man-made fibres formed as a small, short, hard-packed cylinder (a roll) that is used as a saliva absorber and intended to absorb moisture from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00075020044129 | GS1 |