AccessGUDID - DEVICE: DORO® Micro Blade (04250435503188)

GUDID

Device Identifier (DI) Information

Brand Name: DORO® Micro Blade
Version or Model: 3116-22
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Primary DI Number: 04250435503188
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 313517922 *Terms of Use

Device Description: DORO® Micro Blade, 124 x 4 mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

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 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.

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

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K001808	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2c258a26-ccc7-4cb5-8c3d-6862fb2d569f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 09, 2016