AccessGUDID - DEVICE: ERA Implant® Surgical Kit, Complete (00841549114526)

GUDID

Device Identifier (DI) Information

Brand Name: ERA Implant® Surgical Kit, Complete
Version or Model: 905119
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: STERNGOLD DENTAL LLC

Primary DI Number: 00841549114526
Issuing Agency: GS1
Commercial Distribution End Date: August 07, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 124763728 *Terms of Use

Device Description: The ERA Implant Surgical Kit consists of various surgical tools such as drills, countersinks, bone taps, insertion tools and torque wrenches. Intended to be used during implant surgical procedure to drill, bone tap or countersink bone or tissue in the mandible or maxilla of patient. It consists of surgical tools needed for the implant surgical procedure.

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?
45145	Dental/maxillofacial surgical procedure kit, medicated, reusable	A collection of various dental/surgical instruments, dressings, pharmaceuticals and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZE	Implant, Endosseous, Root-Form

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041271	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: 8e349f9e-346d-4a53-bb80-6797645be789
Public Version Date: August 10, 2020
Public Version Number: 2
DI Record Publish Date: July 07, 2020