AccessGUDID - DEVICE: Inserter for plastic vent tubes with (04250676733436)

GUDID

Device Identifier (DI) Information

Brand Name: Inserter for plastic vent tubes with
Version or Model: 10-759-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-759-00
Company Name: Spiggle & Theis Medizintechnik GmbH

Primary DI Number: 04250676733436
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332893028 *Terms of Use

Device Description: one each mandrin for 1.00 mm and 1.2 mm diameter

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":	Yes
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?
33404	Tympanostomy tube inserter, reusable	A hand-held device intended to direct the insertion and placement of a tympanostomy tube (otherwise known as a myringotomy tube, grommet or an aural vent tube) through the external ear canal during ear/nose/throat (ENT) surgery. A tympanostomy tube is a device used to provide drainage from the middle ear through the tympanic membrane; the inserter is removed once the tube has been inserted. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRC	INSTRUMENT, ENT MANUAL SURGICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: e3829ce4-e1e9-4cc5-b2c0-1b81eea2dda7
Public Version Date: July 20, 2023
Public Version Number: 1
DI Record Publish Date: July 12, 2023