FDA.report

Symmetry Surgical

Primary DI
00887482116708
Brand
Symmetry Surgical
Company
SYMMETRY SURGICAL INC.
Model
62-2210S
Catalog number
62-2210S
Device description
Baron Obturator (Stylet) Wire 3 French
Published
2017-12-13
Public version status
Update
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

Product Codes

CodeName
JZFTube, Ear Suction

Product Code Classifications

CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887482116708PrimaryGS10

GMDN Terms

TermDefinition
Tracheostomy tube obturatorA device designed to fill the lumen of a tracheostomy tube during its insertion into the stoma created in the larynx (windpipe) to assist in this process, reduce patient trauma, and prevent any tissue damage. When the tracheostomy tube is correctly positioned the obturator is removed. It is typically a thin rod with a bulbous rounded distal end that protrudes out of the tracheostomy tube, and a knob-like handle used to remove it. It is typically made of a high-grade stainless steel and/or silver (Ag) or silver plated brass. This is a reusable device.

Device Sizes

TypeValueUnit
Catheter Gauge3French

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags

DUNS number
079641356
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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