DEVICE: DORO LUNA® Retractor System (04250435519639)

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Device Identifier (DI) Information

DORO LUNA® Retractor System
1203.220

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
04250435519639
GS1
1
DORO LUNA® Compact Retractor System & DORO® QR3 Headrest System consisting of: 3116-151 3116-141 3116-131 3116-121 3116-111 1201.091 1203.091 1201.006 1203.004 1203.003 1203.002 1203.001 3001-00 3002-00 1001.001
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
No
Yes
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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.
Skull clamp A U-shaped surgical device that is attached to the skull to hold the head and neck in a particular fixed position during surgical procedures. Pointed screws are extended from this device and screwed into the patient's skull, typically one on either side of the forehead whilst the other end is fixed to an operating table or chair where the patient is correctly positioned. It is commonly known as a Mayfield skull clamp, and typical applications include neurosurgical procedures. It is made of metal materials (non-radiolucent) with adjustable joints to allow variable head positioning and is generally not intended for applying traction forces to the cervical spine. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
HBL Holder, Head, Neurosurgical (Skull Clamp)
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
December 15, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
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No
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Customer Contact

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No Customer Contact currently defined
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