AccessGUDID - DEVICE: Brånemark System® (07332747024692)

GUDID

Device Identifier (DI) Information

Brand Name: Brånemark System®
Version or Model: 28854
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 28854
Company Name: Nobel Biocare AB

Primary DI Number: 07332747024692
Issuing Agency: GS1
Commercial Distribution End Date: June 13, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 353939929 *Terms of Use

Device Description: Twist Drill Brånemark System® NP 1.3 mm

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?
61030	Screw extractor, single-use	A hand-held manual surgical tool designed to remove implanted screws that have a damaged screw recess by self-tapping into the defective recess/head and providing sufficient grip to rotate and remove the screw in the normal way. It typically has a conical tip. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZI	DRILL, BONE, POWERED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Outer Diameter: 1.300 Millimeter

Device Record Status

Public Device Record Key: befba162-1073-4438-881a-3c10c454b437
Public Version Date: July 18, 2023
Public Version Number: 6
DI Record Publish Date: September 17, 2016