AccessGUDID - DEVICE: TRUMATCH (05420060381072)

GUDID

Device Identifier (DI) Information

Brand Name: TRUMATCH
Version or Model: SD980.107
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SD980.107
Company Name: Materialise NV

Primary DI Number: 05420060381072
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 373139427 *Terms of Use

Device Description: TRUMATCH TI Implant - Mandible -small

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:	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?
46644	Craniofacial fixation plate kit, non-bioabsorbable	A collection of small sheets of firm material and bone screws, of various shapes/sizes, that are implanted onto fractured craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the components are made of a material that is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Tools for implantation may be included. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JEY	Plate, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173039	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: cf237a82-7926-4fb4-837e-a7ec7936b2b8
Public Version Date: November 19, 2018
Public Version Number: 1
DI Record Publish Date: October 19, 2018

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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