AccessGUDID - DEVICE: InnerView® System Handpiece (00860011518303)

GUDID

Device Identifier (DI) Information

Brand Name: InnerView® System Handpiece
Version or Model: INV-1000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: INV-1000
Company Name: Perimetrics, Inc.

Primary DI Number: 00860011518303
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 036802075 *Terms of Use

Device Description: QPD Measurement Instrument

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?
67338	Dental stability percussive analysis handpiece	A hand-held, electrically-powered, dental device which consists of a handpiece with controls and a moving tip intended to provide percussion (tapping) to the tooth/teeth and/or dental implant(s) to assess the stability of the tooth, implant and/or periodontium (e.g., for movability or presence of fractures/gap defects) via the acquired force-time measurements; it is not intended for attachment to a dental implant (i.e., is not intended for resonance frequency analysis). It is intended to transmit the measurements to an off-the-shelf computerized device with a dedicated software (not included) for processing and display. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKX	Handpiece, Direct Drive, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232657	000

Device Exempt from Premarket Submission: No 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: ccae0bbb-4eed-4e38-bdbc-158b93ed0c2e
Public Version Date: March 13, 2025
Public Version Number: 1
DI Record Publish Date: March 05, 2025

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-888-325-7218
Email: xx@xx.xx

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