AccessGUDID - DEVICE: NobelReplace® (07332747009644)

GUDID

Device Identifier (DI) Information

Brand Name: NobelReplace®
Version or Model: 32301
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 32301
Company Name: Nobel Biocare AB

Primary DI Number: 07332747009644
Issuing Agency: GS1
Commercial Distribution End Date: March 01, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 353939929 *Terms of Use

Device Description: NOBELREPLACE® Straight Surgery Kit. The kit includes instruments to perform implant surgery for RP implants

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:	Yes
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?
45147	Dental/maxillofacial surgical procedure kit, non-medicated, reusable	A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. 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 [?]
K990846	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: 699cffbb-b6ca-4e21-adc4-825efc1f5ec8
Public Version Date: December 11, 2019
Public Version Number: 5
DI Record Publish Date: September 17, 2016