AccessGUDID - DEVICE: EDTA (00883205105431)

GUDID

Device Identifier (DI) Information

Brand Name: EDTA
Version or Model: 162
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 162
Company Name: ULTRADENT PRODUCTS, INC.

Primary DI Number: 00883205105431
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013369913 *Terms of Use

Device Description: EDTA 18% Solution IndiSpense Refill

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:	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?
45233	Endodontic reaming aid material	A liquid or gel substance typically used during root canal procedures as a chelating agent for chemical reaming to aid mechanical reaming, or as a lubricant to facilitate endodontic instrument penetration. It will typically have bactericidal properties. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KJJ	CLEANSER, ROOT CANAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K934415	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
Storage Environment Temperature: between 18 and 29 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e07b8a78-c1cd-4888-b5eb-fc1dbcdb49b7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 10, 2017

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: No Unit of Use DI Numbers Found 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(801)572-4200
Email: customerservice@ultradent.com

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