DEVICE: DORO® Micro Blade (04250435503188)
Device Identifier (DI) Information
DORO® Micro Blade
3116-22
In Commercial Distribution
pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
3116-22
In Commercial Distribution
pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
DORO® Micro Blade, 124 x 4 mm
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Surgical retractor/retraction system blade, reusable | A component of a surgical retraction system or surgical retractor designed to function as a parting edge to separate the margins of a wound/incision during an open surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle because it is available in a variety of lengths and sizes. It is made of high-grade stainless steel. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HBL | Holder, Head, Neurosurgical (Skull Clamp) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K001808 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
2c258a26-ccc7-4cb5-8c3d-6862fb2d569f
July 06, 2018
3
December 09, 2016
July 06, 2018
3
December 09, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined