AccessGUDID - DEVICE: PILLING (14026704719768)

GUDID

Device Identifier (DI) Information

Brand Name: PILLING
Version or Model: IPN916162
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 507924
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704719768
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 24026704417265

Device Description: MALONEY TUNGSTEN FILLED BOUGIE 24 FRENCH

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?
35052	Oesophageal bougie, reusable	A cylindrical, rod-like, surgical instrument that is used to explore and/or dilate a stricture during oesophagoscopic or bronchoscopic procedures. It may be designed with a semi-rigid tapered end (Maloney type) or with a blunt end (Hurst type), and may be hollow for the passing of other slender devices through it. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FAT	Bougie, esophageal, and gastrointestinal, gastro-urology

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: 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
Length: 75 Centimeter

Device Record Status

Public Device Record Key: c444d428-85bb-4db6-aba7-d52cf9ba191f
Public Version Date: March 19, 2021
Public Version Number: 1
DI Record Publish Date: March 11, 2021