FDA.report

INTRODUCER SHAFT

Primary DI
B09928005140
Brand
INTRODUCER SHAFT
Company
SONTEC INSTRUMENTS, INC.
Model
2800-514
Device description
HEARTLINE INTRODUCER SHAFT
Published
2016-08-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FFORetractor, Self-Retaining

Product Code Classifications

CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B09928005140PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during an open surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle because it is available in a variety of lengths and sizes. It is made of high-grade stainless steel. This is a reusable device.

Device Sizes

TypeValueUnit
Length6.25Inch

Sterilization Methods

Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts

PhoneEmail
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
false
Sterilization required before use
true

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