AccessGUDID - DEVICE: Two-sided angling blade holder for BluCLAS (04057034284797)

GUDID

Device Identifier (DI) Information

Brand Name: Two-sided angling blade holder for BluCLAS
Version or Model: UL7087
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UL7087
Company Name: Geister Medizintechnik GmbH

Primary DI Number: 04057034284797
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 343548848 *Terms of Use

Device Description: Two-sided angling blade holder for BluCLAS G BLUE LABEL™

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":	Yes
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35967	Surgical retraction system mounting frame, reusable	A noninvasive mounting device (e.g., a large ring, table-fixed bridging bar) designed as a component of a surgical retraction system, intended to be placed/fixed around a surgical incision site and upon which retraction system blades/components are mounted to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during surgery. It does not include the invasive retraction blades/components (i.e., is not the complete system). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZT	RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 412f3701-d6ff-414d-878e-3e7416ba4cc6
Public Version Date: November 19, 2018
Public Version Number: 1
DI Record Publish Date: October 18, 2018