FDA.report

Benjamin Slim Operating Laryngoscope

Primary DI
00192896116276
Brand
Benjamin Slim Operating Laryngoscope
Company
SONTEC INSTRUMENTS, INC.
Model
485-1327
Catalog number
485-1327
Device description
Benjamin Slim Operating Laryngoscope Adult Medium
Published
2024-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JZFTUBE, EAR SUCTION

Product Code Classifications

CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896116276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896116276001928961162761928961162760192896116276

GMDN Terms

TermDefinition
Surgical/emergency suction cannula, illuminating, reusableAn atraumatic, invasive, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or clear an airway obstruction, whilst providing illumination of the site. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic, nor an intravascular device; it is not designed for surgical irrigation. It has a built-in light or fibreoptic bundle used to illuminate the operative site. Often referred to a as suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or tubing. This is a reusable device.

Device Sizes

TypeValueUnit
Length6.75Inch

Sterilization Methods

Method
Dry Heat Sterilization

Contacts

PhoneEmail
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags

DUNS number
040729840
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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