AccessGUDID - DEVICE: MGUIDE® (07392532253157)

GUDID

Device Identifier (DI) Information

Brand Name: MGUIDE®
Version or Model: MG-STN2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DENTSPLY IH, INC.

Primary DI Number: 07392532253157
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 847337201 *Terms of Use

Device Description: MGUIDE - 2 implants

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?
63484	Dental implantation drilling template, custom-made	A custom-made device intended to be used by a dental surgeon to guide drilling in the jawbone of a patient during the first stage of a guided dental implantation procedure for dental implant or orthodontic mini-implant placement/fixation. It is in the form of a shaped plate with a predefined hole(s) or a thermoformed mouldable cylinder and is capable of being used on fully and partially edentulous patients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDP	Accessories, implant, dental, endosseous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: fa14f3ea-1e33-4950-bb85-80492000f3fb
Public Version Date: April 12, 2024
Public Version Number: 1
DI Record Publish Date: April 04, 2024

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

[?]

Phone: +1(800)531-3481
Email: implants-na-cs@dentsply.com

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