AccessGUDID - DEVICE: G-aenial™ (D0470046351)

GUDID

Device Identifier (DI) Information

Brand Name: G-aenial™
Version or Model: 004635
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 004635
Company Name: Gc America Inc.

Primary DI Number: D0470046351
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 005473608 *Terms of Use

Device Description: G-aenial™ DISPENSINGTIPS III, Needle Tip, 30 pcs

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?
38764	Light-cured dental restorative composite resin	A dental restorative material that consists of a blend of filler particles (e.g., glass, ceramic, zirconia, silica) mixed with a synthetic, photo-polymerizable, organic resin matrix [e.g., bisphenol A-glycidyl methacrylate (BISGMA), urethane dimethacrylate (UDMA)] intended to fill dental cavities or restore damaged hard dental tissue. It is typically a one-part paste, contained within an application syringe or capsule, that requires a light source of specific wavelengths (e.g., 460 to 480 nm) to initiate resin polymerization/hardening post application; it is typically available in tooth-coloured shades. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	MATERIAL, TOOTH SHADE, RESIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090747	000
K091388	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: c3afd78c-0626-40aa-873a-e5c411b2bb50
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 01, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: D0470046350 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(708)597-0900
Email: customerservice@gcamerica.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES