DEVICE: N/A (04052536083619)

Device Identifier (DI) Information

N/A
CS 3890-021-001
In Commercial Distribution
CS 3890-021-001
Ulrich GmbH & Co. KG
04052536083619
GS1

1
315494757 *Terms of Use
Layer P1.1 for uCentum instruments percutaneous approach
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

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 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.
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FDA Product Code

[?]
Product Code Product Code Name
MNH Orthosis, spondylolisthesis spinal fixation
NKB Orthosis, spinal pedicle fixation, for degenerative disc disease
MNI ORTHOSIS, SPINAL PEDICLE FIXATION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

70e67de1-31cf-49e9-9e06-5fd9c3b85ce2
March 29, 2018
2
July 30, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+4907319654152
safety@ulrichmedical.com
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