AccessGUDID - DEVICE: DORO® Retractor System (04250435506561)

GUDID

Device Identifier (DI) Information

Brand Name: DORO® Retractor System
Version or Model: 1202.100T
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Primary DI Number: 04250435506561
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 313517922 *Terms of Use

Device Description: DORO® Quick-Clamp Halo Retractor System consisting of: 3117-00 3116-26 3116-25 3116-24 3116-23 3116-22 3116-21 3116-151 3116-141 3116-131 3116-121 3116-111 1202.016 1202.015 1202.014 3114-37 3110-85 3110-80 3110-08 3110-01

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46774	Surgical retractor/retraction system blade, reusable	A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a 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 a metal device, 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. This is a reusable device.	Active	false
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.	Active	false

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

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: 1bcf92ab-bd27-44c0-bc41-642db6c3d2e3
Public Version Date: May 10, 2021
Public Version Number: 6
DI Record Publish Date: December 15, 2016