AccessGUDID - DEVICE: Inclusive (D745701066MNP00071)

GUDID

Device Identifier (DI) Information

Brand Name: Inclusive
Version or Model: 70-1066-MNP0007
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-1066-MNP0007
Company Name: Prismatik Dentalcraft, Inc

Primary DI Number: D745701066MNP00071
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 022761689 *Terms of Use

Device Description: Inclusive Mini Implant Instrumentation O-Rings 2.5 mm x 1 mm (5-pack)

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):	No
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?
44806	Surgical instrument seal/seal maintenance set	A seal/collection of seals (e.g., O-rings, shaped or viscous gaskets) intended to be used to replace a damaged sealing component in the maintenance of certain endoscopes, microscopes, injectors, or other surgical instruments. It may include supportive hand tools (screwdrivers). It is not a laparoscopic access cannula seal.	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
Device Size Text, specify: Inner Diameter, 2.5 mm

Device Record Status

Public Device Record Key: c542f14c-c4a3-46e5-81dc-ebcadfc1c293
Public Version Date: August 09, 2024
Public Version Number: 4
DI Record Publish Date: October 07, 2016