AccessGUDID - DEVICE: 5mm Offset Shielded 15 Degree Abutment (D7855250TSIS0)

GUDID

Device Identifier (DI) Information

Brand Name: 5mm Offset Shielded 15 Degree Abutment
Version or Model: Offset Shielded 15 Degree Abutment
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5250 TSI S
Company Name: OCO BIOMEDICAL INC

Primary DI Number: D7855250TSIS0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094146123 *Terms of Use

Device Description: 5mm Diameter Offset Shielded 15 Degree Abutment Short

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Dental implant system	A collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

FDA Product Code

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Product Code	Product Code Name
NHA	Abutment, Implant, Dental, Endosseous

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
No Device Sizes

Device Record Status

Public Device Record Key: f76c79cb-fa33-4cbb-9c97-dcc0740c2060
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: March 22, 2016