AccessGUDID - DEVICE: Montgomery® Laryngeal Keel (14063107100502)

GUDID

Device Identifier (DI) Information

Brand Name: Montgomery® Laryngeal Keel
Version or Model: 323040R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 323040R
Company Name: Boston Medical Products, Inc.

Primary DI Number: 14063107100502
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 131855157 *Terms of Use

Device Description: Size: 12 mm; Type: Radiopaque

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?
42672	Polymeric laryngeal stent	A sterile non-bioabsorbable device intended to be implanted in the larynx for the prevention and treatment of laryngeal stenosis and/or chronic aspiration postoperatively. It is typically a hollow, semi-soft moulded device made of a synthetic polymer(s) (e.g., silicone) intended to conform to the endolaryngeal surface. Disposable devices intended to assist implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FWN	Prosthesis, Larynx (Stents And Keels)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K962693	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
Device Size Text, specify: Length (Base): 21 mm
Device Size Text, specify: Width (Base): 16 mm
Device Size Text, specify: Length (Keel): 17 mm
Device Size Text, specify: Height (Keel): 12 mm

Device Record Status

Public Device Record Key: 40c4d9e8-944f-4f09-a330-f7c27e40ed29
Public Version Date: October 07, 2022
Public Version Number: 1
DI Record Publish Date: September 29, 2022