FDA.report

INTERSURGICAL INTERFORM INTUBATING STYLET, SIZE 14FR, OD 4.7MM

Primary DI
05030267110261
Brand
INTERSURGICAL INTERFORM INTUBATING STYLET, SIZE 14FR, OD 4.7MM
Company
INTERSURGICAL INCORPORATED
Model
8080014
Device description
INTERSURGICAL INTERFORM INTUBATING STYLET, SIZE 14FR, OD 4.7MM
Published
2021-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BSRStylet, Tracheal Tube

Product Code Classifications

CodeDeviceSpecialtyClass
BSRStylet, Tracheal TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05030267110261PackageGS110In Commercial Distribution
05030267109579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267110261050302671102615030267110261
05030267109579050302671095795030267109579

GMDN Terms

TermDefinition
Artificial airway stylet, single-useA sterile, long, stiffening wire/rod designed for insertion within the lumen of an artificial airway tube (e.g., endotracheal tube, bronchial tube) to stiffen and/or maintain the shape of the tube to facilitate introduction (intubation). It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags

DUNS number
785952607
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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