AccessGUDID - DEVICE: Neuro Plating System (08809595972950)

GUDID

Device Identifier (DI) Information

Brand Name: Neuro Plating System
Version or Model: TSN-012
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OSTEONIC CO.,Ltd.

Primary DI Number: 08809595972950
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688999370 *Terms of Use

Device Description: 1x Screw disk + 100 screws 4mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
46879	Cranioplasty plate screw	A small, threaded rod with a slotted head designed to fasten skull plates (i.e., plates with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult) to the intact cranial bones. It is typically made of metal [e.g., stainless steel, titanium (Ti)] and has a length and diameter appropriate to match the plate holes and the cranial bones. It is used mainly in neurosurgical procedures intended to fix cranioplasty plates used to repair defects created or caused by injury, surgical intervention for tumour removal, or congenital anomaly or disease.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HBW	Fastener, Plate, Cranioplasty
GXR	Cover, Burr Hole
GWO	Plate, Cranioplasty, Preformed, Alterable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183352	000
K190811	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: c77830cb-3414-481b-a0ad-ff9095f8928c
Public Version Date: February 19, 2024
Public Version Number: 4
DI Record Publish Date: February 13, 2019

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

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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