FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: H65811250560
·
Model: 1125056
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- H65811250560
- Version / Model
- 1125056
- Catalog Number
- 1125056
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- fd52e987-f60c-4a8b-abea-474cf224a577
Device Description
Endo Cool Spray
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| EAT | Tester, pulp | Dental | 872.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38787 | Cryogenic spray, dental | A liquid/gaseous refrigerant, typically contained in an aerosol or other spray dispenser, which is applied (sprayed) to a tooth to chill it, primarily to observe the patient's resulting intensity and duration of sensation in the evaluation of dental pulp vitality (i.e., helps to determine if the pulp is normal, inflamed, or necrotic). Some refrigerants may be used as a local anaesthetic when extracting deciduous teeth in children. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H65811250561 | HIBCC | Box | 12 | In Commercial Distribution | |
| Primary | H65811250560 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K930764 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 50 Degrees Celsius