FDA UDI
Not in Commercial Distribution
🇺🇸 United States
HOTSY
DI: 00893398002547
·
Model: Cautery High Temperature Loop Tip
·
SHIPPERT MEDICAL TECHNOLOGIES, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HOTSY
- Primary DI
- 00893398002547
- Version / Model
- Cautery High Temperature Loop Tip
- Catalog Number
- 20-HM-1000
- Company Name
- SHIPPERT MEDICAL TECHNOLOGIES, INC
- Labeler DUNS
- 051437143
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-12
- Public Version
- 5
- Public Version Date
- 2023-05-08
- Public Version Status
- Update
- Public Device Record Key
- 60b9f310-831a-4de8-a8c2-379665fe01a3
- Distribution End Date
- 2023-01-01
Device Description
Disposable High-Temperature (2000° C) Loop Tip Cautery battery operated with batteries installed. Unit has a four year shelf life.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HQP | Unit, Cautery, Thermal, Battery-Powered | Ophthalmic | 886.4115 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45631 | Electrocautery system handpiece | An electrode handpiece that functions as the holder for a detachable cautery electrode, which together become the conducting unit, providing a means of conducting an electrical current used to heat the electrode tip used during surgical intervention to burn or sear body tissue. It will typically be made of heat and electrical resistant materials and include the cables/plugs that connect to the generator. This device can be used for, e.g., to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00893398002547 | GS1 | ||||
| Package | 10893398002544 | GS1 | Box | 10 | Not in Commercial Distribution | 2023-05-08 |
Customer Contacts
- Phone
- 303-754-0044
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Loop Tip |