DEVICE: Bio Protech (00817120020289)
Device Identifier (DI) Information
Bio Protech
9551F
In Commercial Distribution
BIO PROTECH USA, INC.
9551F
In Commercial Distribution
BIO PROTECH USA, INC.
9551F- Grounding Pads, Dispersive Electrode, Adult, Foam, Non-Corded, Single Pad, Horizontal (5 pcs/pouch, 40 pouches in Master Case) DO NOT USE
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
58494 | Electrosurgical return electrode, single-use |
A dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEI | Electrosurgical, Cutting & Coagulation & Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K073360 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
3e68f577-6716-4671-b91b-aa1316848f9f
June 05, 2020
4
June 28, 2016
June 05, 2020
4
June 28, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10817120020286 | 40 | 00817120020289 | In Commercial Distribution | Inner Box | |
20817120020283 | 2 | 10817120020286 | 2017-06-05 | Not in Commercial Distribution | Master Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
714-730-9950
Bioprotechusa@gmail.com
Bioprotechusa@gmail.com