AccessGUDID - DEVICE: Frontal sinus seeker (04250381813232)

GUDID

Device Identifier (DI) Information

Brand Name: Frontal sinus seeker
Version or Model: 30-207-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30-207-01
Company Name: Spiggle & Theis Medizintechnik GmbH

Primary DI Number: 04250381813232
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332893028 *Terms of Use

Device Description: double ended, slightly curved 20.5 cm

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?
35253	Paranasal sinus probe	A hand-held manual surgical instrument designed for introduction into the air cavities in the cranial bones which communicate with the nasal cavity (i.e., paranasal sinuses) to explore and/or dilate strictures in the passages from the nose to the communicating sinuses, typically during ear/nose/throat (ENT) surgery. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KAK	PROBE, ENT

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: 3c32cfb6-eab2-4de9-b708-f78628ab1017
Public Version Date: September 30, 2022
Public Version Number: 1
DI Record Publish Date: September 22, 2022