AccessGUDID - DEVICE: IPD (08435566616907)

GUDID

Device Identifier (DI) Information

Brand Name: IPD
Version or Model: AINC3D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IPD/KR-IR-35
Company Name: IMPLANT PROTESIS DENTAL 2004 SL

Primary DI Number: 08435566616907
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 467871518 *Terms of Use

Device Description: Cutting guide Non-Engaging Regular H 3.5

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:	No
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?
63664	Dental implant suprastructure reamer guide	A manually-operated dental laboratory instrument intended to help guide a manual reamer during smoothing and refining of the surface of the screw channel, screw seat and implant/abutment connection of a dental implant suprastructure, to remove minor casting flashes during the production of a final suprastructure; it is not intended for intraoral use. Also referred to as a reamer gauge, it is in the form of a support with a flat base and slots for mounting the suprastructure and inserting the reamer. This is a reusable 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: 078c46cc-0538-4c27-8d73-bbbaca55af46
Public Version Date: August 02, 2023
Public Version Number: 2
DI Record Publish Date: June 09, 2023

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: Yes
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: +13057983869
Email: burbina@ipd2004.com

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