FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Monopolar High Frequency Cord Male to Female Connector
DI: 00801741077289
·
Model: 5601100
·
Davol Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Monopolar High Frequency Cord Male to Female Connector
- Primary DI
- 00801741077289
- Version / Model
- 5601100
- Catalog Number
- 5601100
- Company Name
- Davol Inc.
- Labeler DUNS
- 001191048
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-02-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- ec101fd8-38db-4e96-88cb-b905e9b05423
- Distribution End Date
- 2017-05-31
Device Description
Monopolar High Frequency Cord Male to Female Connector
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
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 47487 | Electrical-only medical device connection cable, reusable | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00801741077289 | GS1 | ||||
| Package | 10801741077286 | GS1 | Other | 1 | Not in Commercial Distribution | 2017-05-31 |
Customer Contacts
- Phone
- +1(800)562-0027
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K911274 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 65 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius