FDA UDI
In Commercial Distribution
🇺🇸 United States
EPITOME
DI: H671CBE2000
·
Model: Epitome .2
·
UTAH MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- EPITOME
- Primary DI
- H671CBE2000
- Version / Model
- Epitome .2
- Catalog Number
- CBE-200
- Company Name
- UTAH MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 094651270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2019-12-18
- Public Version Status
- Update
- Public Device Record Key
- a165179c-c9a6-4db7-a266-35578192cb06
Device Description
Disposable Electrosurgical Electrode, 3/4" (19mm) Blade Length, Standard 2" (5cm) Shaft Length, 0.2mm Wire Diameter
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
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61874 | Open-surgery electrosurgical electrode, monopolar, single-use | An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H671CBE2002 | HIBCC | Overpack | 10 | In Commercial Distribution | |
| Package | H671CBE2001 | HIBCC | Box | 25 | In Commercial Distribution | |
| Primary | H671CBE2000 | HIBCC |
Customer Contacts
- Phone
- 800-533-4984
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Wire Diameter - 0.2 mm | ||
| Device Size Text, specify | Shaft Length - 2" (5cm) | ||
| Device Size Text, specify | Blade Length - 0.75" (19mm) |