AccessGUDID - DEVICE: PiezoImplant System (D894B2155C0)

GUDID

Device Identifier (DI) Information

Brand Name: PiezoImplant System
Version or Model: REX BL 2.9 x 5 H15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B2-155C
Company Name: Rex Implants, Inc.

Primary DI Number: D894B2155C0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080746478 *Terms of Use

Device Description: REX BL 2.9 x 5 H15 packaged with Cover Screw BL 2.9

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?
55847	Dental implant system	A collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NRQ	Blade-Form Endosseous Dental Implant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211872	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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 15 Millimeter
Width: 5 Millimeter

Device Record Status

Public Device Record Key: 766f97c0-6c7a-4251-bb1c-17c8a7685a44
Public Version Date: January 02, 2023
Public Version Number: 1
DI Record Publish Date: December 24, 2022