AccessGUDID - DEVICE: LONG DRILL DIAM. 3,60 MM (D7701048603)

GUDID

Device Identifier (DI) Information

Brand Name: LONG DRILL DIAM. 3,60 MM
Version or Model: GS-F360-L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GS-F360-L
Company Name: SWEDEN & MARTINA SPA

Primary DI Number: D7701048603
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 433815198 *Terms of Use

Device Description: LONG DRILL DIAM. 3,60 MM FOR GUIDED SURGERY

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):	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?
44883	Dental implant/prosthesis surgical procedure kit	A collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes. This is a reusable device.	Obsolete	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: 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: aa5a75c5-e22f-417f-8d46-445e42801e80
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 23, 2016