FDA UDI
In Commercial Distribution
🇺🇸 United States
CryoDose TA
DI: 00856331006248
·
Model: 1805
·
NUANCE MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CryoDose TA
- Primary DI
- 00856331006248
- Version / Model
- 1805
- Catalog Number
- 1805
- Company Name
- NUANCE MEDICAL, LLC
- Labeler DUNS
- 078797666
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-25
- Public Version
- 2
- Public Version Date
- 2021-07-15
- Public Version Status
- Update
- Public Device Record Key
- 500d8280-03f9-49c4-831f-07b38a93b8f4
Device Description
CryoDose TA Topical Anesthetic Mini Mist Spray, 30 mL
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| MLY | REFRIGERANT, TOPICAL (VAPOCOOLANT) | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46557 | Cold/cool therapy spray | A non-sterile liquid (e.g., alcohol based) in a spray container intended for localized application to the body surface to provide a cooling effect for underlying muscles/joints to reduce pain and swelling typically from sports injuries (cold therapy), and/or for cooling at the skin surface to treat heat rash or hot flushes (cool therapy); it may be intended to be applied to the skin directly or used in combination with a moist-cold pack/bandage (i.e., used to soak the moist-cold pack/bandage). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856331006248 | GS1 | ||||
| Package | 10856331006245 | GS1 | Shipper | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(760)585-4849 ext. 0
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 35 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 120 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- do not store near direct heat source