FDA UDI
In Commercial Distribution
🇺🇸 United States
Isolite Moutpiece
DI: 00810032660239
·
Model: CIL1101
·
ZYRIS, INC.
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Isolite Moutpiece
- Primary DI
- 00810032660239
- Version / Model
- CIL1101
- Catalog Number
- CIL1101
- Company Name
- ZYRIS, INC.
- Labeler DUNS
- 068038277
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2019-09-24
- Public Version
- 2
- Public Version Date
- 2024-04-22
- Public Version Status
- Update
- Public Device Record Key
- 0149dcf4-5056-4b1e-a2a7-e3bedfef577a
Device Description
Mouthpiece, 10-Pack, Extra Small
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DYN | Mouthpiece, saliva ejector | Dental | 872.6640 | 1 |
| EIF | ACCESSORIES, RETRACTOR, DENTAL | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13380 | Hand-held dental retractor | A hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device. | No | Active |
| 66751 | Dental suction protective mouthpiece | A prefabricated device designed to be placed in the oral cavity during a dental procedure to protect the oral pathway by serving as a conduit for the continuous suction of debris/saliva, shielding the oral anatomy, maintaining an open mouth and retracted cheeks, and depressing the tongue. It is made of preformed materials for direct insertion into the mouth and includes features for connection to a dental suction unit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810032660239 | GS1 | ||||
| Unit of Use | 10810032660236 | GS1 |
Customer Contacts
- Phone
- +1(800)560-6066
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 55 Degrees Celsius