FDA.report

ANKENEY STERNAL RETRACTOR BLADE

Primary DI
00192896093751
Brand
ANKENEY STERNAL RETRACTOR BLADE
Company
SONTEC INSTRUMENTS, INC.
Model
2500-200BL
Catalog number
2500-200BL
Device description
ANKENEY STERNAL RETRACTOR BLADE
Published
2019-03-07
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

Contact Domains

Product Codes

CodeName
FFORETRACTOR, SELF-RETAINING
GADRetractor

Product Code Classifications

CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896093751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896093751001928960937511928960937510192896093751

GMDN Terms

TermDefinition
Rib spreader, reusableA self-locking surgical instrument designed to force apart two adjacent ribs to permit examination or intervention in the thoracic cavity. This device will typically have two interchangeable blades at the distal end that hook over the ribs to be parted, and a ratchet mechanism along its horizontal bar to adjust the blades and maintain its set position once it has been set. It is also known as a rib retractor and is available in various designs and sizes. It is typically made of high-grade stainless steel but types used for paediatrics may be made of corrosive resistant aluminium (Al). This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts

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

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