FDA UDI
In Commercial Distribution
🇺🇸 United States
Mirror Cotton Holders
DI: 00723896010068
·
Model: 1604-P01
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- Mirror Cotton Holders
- Primary DI
- 00723896010068
- Version / Model
- 1604-P01
- Catalog Number
- 70-42625
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2018-07-18
- Public Version
- 1
- Public Version Date
- 2018-08-20
- Public Version Status
- New
- Public Device Record Key
- 1fb1bd09-f843-4d59-8164-506dd0fa0cbd
Device Description
snap onto size 4 and size 5 mouth mirrors and feature twin tabs to keep both lingual and buccal cotton rolls in place during lower posterior procedures. Easily reversible for left or right quadrants. 100 single-use, disposable holders per bag. Not for use with Zirc mouth mirrors.
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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| EAX | Mirror, Mouth | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 00723896010075 | GS1 | Case | 120 | In Commercial Distribution | |
| Primary | 00723896010068 | GS1 | ||||
| Unit of Use | 00723896008225 | GS1 |