AccessGUDID - DEVICE: Drill Extender (10841307119128)

GUDID

Device Identifier (DI) Information

Brand Name: Drill Extender
Version or Model: DE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DE
Company Name: IMPLANT DIRECT SYBRON MANUFACTURING LLC

Primary DI Number: 10841307119128
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 868856969 *Terms of Use

Device Description: No description.

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?
45320	Dental drill bit extension	A device intended to be attached to the shaft of a normal dental drill bit in order to lengthen it, providing greater accessibility and/or drilling capacity during a dental procedure. It is typically made of a high-grade metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZI	Drill, Bone, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081396	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 3a551b49-b08a-4a27-8993-ea5f13293e55
Public Version Date: November 22, 2018
Public Version Number: 4
DI Record Publish Date: December 29, 2015