AccessGUDID - DEVICE: Har-El Pharyngeal Tube (EBES3551200)

GUDID

Device Identifier (DI) Information

Brand Name: Har-El Pharyngeal Tube
Version or Model: 355120
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 355120
Company Name: Boston Medical Products, Inc.

Primary DI Number: EBES3551200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Size: 12 mm; Type: Clear

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	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?
43684	Polymeric oesophageal stent, non-bioabsorbable	A sterile, non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to temporarily maintain luminal patency in strictures and achalasia, seal fistulas, and/or to treat other lesions (e.g., anastomotic leaks). It is a mesh structure, which may or may not be covered/lined, and is made entirely of a synthetic polymer(s) (e.g., silicone). It is typically expanded in situ (e.g., self-expands) and disposable devices intended to assist implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KCF	Dilator, Esophageal, Ent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K923355	000

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
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Length: 183 Millimeter
Outer Diameter: 12 Millimeter

Device Record Status

Public Device Record Key: c266eed2-1c3f-48ce-aeae-601bbc830d89
Public Version Date: August 30, 2022
Public Version Number: 4
DI Record Publish Date: September 20, 2015