AccessGUDID - DEVICE: N/A (04052536083459)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: CS 3890-011
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CS 3890-011
Company Name: Ulrich GmbH & Co. KG

Primary DI Number: 04052536083459
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315494757 *Terms of Use

Device Description: uCentum instrument tray 1 open and percutaneous approach

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:	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
Sterilization container	A receptacle designed to hold wrapped and/or unwrapped surgical instruments (e.g. hand-held tools, surgical powered drills, hoses) during sterilization and for their subsequent storage. The container is permeable in order to allow moisture to escape from within after the sterilization process is finished, whilst protecting the contents from being contaminated. It may have features such as an expiry date label, sterile breathing filter, and stacking capabilities. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Sterilization container

A receptacle designed to hold wrapped and/or unwrapped surgical instruments (e.g. hand-held tools, surgical powered drills, hoses) during sterilization and for their subsequent storage. The container is permeable in order to allow moisture to escape from within after the sterilization process is finished, whilst protecting the contents from being contaminated. It may have features such as an expiry date label, sterile breathing filter, and stacking capabilities. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
MNH	Orthosis, spondylolisthesis spinal fixation
NKB	Orthosis, spinal pedicle fixation, for degenerative disc disease
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123717	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: 2c592c02-ee77-439e-a895-f3a473d51e6d
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: July 30, 2016