DEVICE: DORO® Flexible Rotary Arm (04250435502785)
Device Identifier (DI) Information
DORO® Flexible Rotary Arm
3114-36
In Commercial Distribution
pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
3114-36
In Commercial Distribution
pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
DORO® Flexible Rotary Arm 200 mm
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
Yes | |
No | |
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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? |
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45181 | Surgical retraction system, reusable |
A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HBL | Holder, Head, Neurosurgical (Skull Clamp) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K001808 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
5c646322-511f-413f-9531-037428f97faf
March 11, 2021
4
December 15, 2016
March 11, 2021
4
December 15, 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