FDA UDI
In Commercial Distribution
🇺🇸 United States
PenEvac1®, MaxReveal ™ Diamond Crystal®
DI: 00817688024088
·
Model: ICM-000-0696
·
I.C. MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- PenEvac1®, MaxReveal ™ Diamond Crystal®
- Primary DI
- 00817688024088
- Version / Model
- ICM-000-0696
- Catalog Number
- ICM-000-0696
- Company Name
- I.C. MEDICAL, INC.
- Labeler DUNS
- 616182895
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-17
- Public Version
- 2
- Public Version Date
- 2023-11-06
- Public Version Status
- Update
- Public Device Record Key
- 7613f04f-3135-4ca2-87e2-70a937aacfb9
Device Description
PenEvac1®, MaxReveal ™ Diamond Crystal Blade®, 100 mm Guarded Non-Stick Blade, 10 Foot Tube, 10 mm to Filter Connector and Holster, Sterile
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| 61869 | Open-surgery electrosurgical handpiece/electrode, monopolar, single-use | A rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. 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 | 00817688024095 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 00817688024088 | GS1 |
Customer Contacts
- Phone
- 6237800700
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 140 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity