FDA.report

TITANIUM DEBAKEY SUBRAMANIAN SIDEWINDER CLAMP

Primary DI
B09926000100
Brand
TITANIUM DEBAKEY SUBRAMANIAN SIDEWINDER CLAMP
Company
SONTEC INSTRUMENTS, INC.
Model
2600-010
Device description
TITANIUM DEBAKEY SUBRAMANIAN SIDEWINDER CLAMP SPOON JAW
Published
2018-08-28
Public version status
New
Distribution status
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
DXCClamp, Vascular

Product Code Classifications

CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B09926000100PreviousHIBCC0
00192896004498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896004498001928960044981928960044980192896004498

GMDN Terms

TermDefinition
Surgical bulldog clamp, reusableA hand-held manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of high-grade stainless steel. It is commonly used for vascular clamping however it is not dedicated to a specific anatomy/surgery. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Length10.5Inch

Sterilization Methods

Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts

PhoneEmail
800-821-7496info@sontecinstruments.com

Regulatory Flags

DUNS number
040729840
Device count
1
DM exempt
false
Premarket exempt
false
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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