AccessGUDID - DEVICE: NeoZoline (M633S3815400)

GUDID

Device Identifier (DI) Information

Brand Name: NeoZoline
Version or Model: S381540
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S381540
Company Name: JEDMED INSTRUMENT COMPANY

Primary DI Number: M633S3815400
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092987189 *Terms of Use

Device Description: Vent Tube Collar Button 1.14mm Each

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?
33794	Tympanostomy tube	A small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a myringotomy tube, grommet or an aural vent tube, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleus clip tube, attaches to the malleus. Disposable devices associated with implantation may be included with the device, which may be used to implant bilateral tubes.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
ETD	Tube, Tympanostomy

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: Yes
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
Lumen/Inner Diameter: 1.14 Millimeter

Device Record Status

Public Device Record Key: 2491d231-c635-4e77-9b92-b539c81f7e3f
Public Version Date: January 22, 2021
Public Version Number: 3
DI Record Publish Date: October 15, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
M6333815401	10	M633S3815400		In Commercial Distribution	Box

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: 314-845-3770
Email: info@jedmed.com

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