FDA UDI
In Commercial Distribution
🇺🇸 United States
Codman VersaTru™
DI: 10381780521679
·
Model: 9009100ST
·
Integra LifeSciences Switzerland Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Codman VersaTru™
- Primary DI
- 10381780521679
- Version / Model
- 9009100ST
- Catalog Number
- 9009100ST
- Company Name
- Integra LifeSciences Switzerland Sàrl
- Labeler DUNS
- 480186617
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-02
- Public Version
- 5
- Public Version Date
- 2023-05-16
- Public Version Status
- Update
- Public Device Record Key
- f4eba429-6ebf-43fe-beb9-836b2db6a1f9
Device Description
CODMAN VersaTru™ Standard Disposable Non-Stick Bipolar Forceps 9" (23cm), 1.0mm Tip
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 |
|---|---|---|---|---|
| GEI | Electrosurgical, cutting & coagulation & accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56296 | Open-surgery electrosurgical handpiece/electrode, bipolar, single-use | A sterile rigid combined electrosurgical handpiece and bipolar 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780521679 | GS1 | ||||
| Previous | 10886704079989 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162469 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 9 | Inch | |
| Device Size Text, specify | 1 mm Tip |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 105 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 20 – 80 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 80 Degrees Fahrenheit
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 105 KiloPascal
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do Not Use if Package is Damaged