AccessGUDID - DEVICE: Seal-Tight (00615375003732)

GUDID

Device Identifier (DI) Information

Brand Name: Seal-Tight
Version or Model: 72200C
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: METREX RESEARCH, LLC

Primary DI Number: 00615375003732
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 145963778 *Terms of Use

Device Description: Spectrum Disposable AirWater Syringe Tips in Assorted Colors that Deliver Dry Air on Demand

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?
35970	Dental irrigation/aspiration syringe	A hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIA	UNIT, OPERATIVE DENTAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K951238	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: 6806d46e-bb13-4d13-a795-14e7c78b5c31
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 31, 2016