DEVICE: Rospital Productos Medicos (00812460028070)
Device Identifier (DI) Information
Rospital Productos Medicos
SBP21
In Commercial Distribution
SBP21
ATLAS MEDICAL PRODUCTS LLC
SBP21
In Commercial Distribution
SBP21
ATLAS MEDICAL PRODUCTS LLC
SURGICAL BLADES WITH PLASTIC HANDLE - #21 EA.
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? |
---|---|---|---|---|
37445 | Manual scalpel blade, single-use |
An interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GES | Blade, Scalpel |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: SURGICAL BLADES WITH PLASTIC HANDLE - #21 EA. |
Device Record Status
1302b495-eefc-46ac-8bd4-a6d8bea91888
January 22, 2021
3
June 13, 2020
January 22, 2021
3
June 13, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10812460028077 | 10 | 00812460028070 | In Commercial Distribution | INNER | |
20812460028074 | 50 | 10812460028077 | In Commercial Distribution | 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
[?]
786-473-9436
levalenzuela17@gmail.com
levalenzuela17@gmail.com