AccessGUDID - DEVICE: INVISx® (20643169466306)

GUDID

Device Identifier (DI) Information

Brand Name: INVISx®
Version or Model: 60100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC PS MEDICAL, INC.

Primary DI Number: 20643169466306
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 089055867 *Terms of Use

Device Description: LOCKS 60100 INVISX 2PK CE

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?
56730	Cranial bone flap fixation clip	A sterile, non-metallic, non-bioabsorbable device designed to be partially implanted around the perimeter of a replaced cranial bone flap after a craniotomy to ensure structural stability during the healing period. It is typically made of biocompatible plastic materials [e.g., polyoxymethylene (POM), commonly known as Delrin] and is typically designed with internal and external flanges that are tensioned together over the bone of both the flap and skull and locked via a central stem. It may also be used for craniofacial bone fracture fixation. Its non-metallic design makes it more compatible with radiological imaging than metallic clips.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GXN	PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K010361	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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
Width: 2.54 Millimeter

Device Record Status

Public Device Record Key: c4e5d2bd-63fa-4a95-98a9-9ba031989b72
Public Version Date: July 22, 2021
Public Version Number: 5
DI Record Publish Date: July 16, 2015

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: 00643169466302 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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