FDA.reportPublic FDA data

CASALE RETRACTOR BLADE

Primary DI
00192896045767
Brand
CASALE RETRACTOR BLADE
Company
SONTEC INSTRUMENTS, INC.
Model
516-820
Catalog number
516-820
Device description
CASALE RETRACTOR BLADE PEDIATRIC RING MALLEABLE SHAFT
Published
2018-09-18
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXPINSTRUMENT, BENDING OR CONTOURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXPInstrument, Bending Or ContouringOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896045767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896045767001928960457671928960457670192896045767

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

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

Contacts#

Phone, Email table
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
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

Other Devices From This Company#

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Primary DIBrandModelCatalogPublished
00192896015104REEH STITCH SCISSORS13-832513-83252018-09-12
00192896062238RYDER NEEDLE HOLDER2300-3152300-3152018-09-12
00192896105171Small Plates355-236A355-236A2020-10-05
00192896122833Intraocular Set1100-034-SET1100-034-SET2026-03-19
00192896122840Alyea-Babcock Vasectomy Clamp516-695516-6952026-03-19
00192896122857Diamond Head Grasping Forceps1273-1251273-1252026-03-19
00192896122864Velociraptor Junior Rongeur1273-171F1273-171F2026-03-19
00192896122871Spoon Curette2900-2222900-2222026-03-19
00192896122888Dissector2900-2332900-2332026-03-19
00192896122895Ball Dissector2900-2352900-2352026-03-19
00192896122901Hook Dissector2900-2372900-2372026-03-19
00192896122918Hook Dissector2900-2382900-2382026-03-19
00192896122925Spatula Dissector2900-2422900-2422026-03-19
00192896122932Spatula Dissector2900-2442900-2442026-03-19
00192896122949Deluxe Alligator Grasping Forceps1100-333D1100-333D2026-03-19
00192896122680Schroeder Vulsellum Bone Clamp1103-0641103-0642026-03-10
00192896122697Cooley Vascular Clamp2100-527C2100-527C2026-03-10
00192896122703Ochsner Dissector2700-155T2700-155T2026-03-10
00192896122710Debakey Coarctation Clamp2100-6312100-6312026-03-10
00192896122727Debakey Coarctation Clamp2100-6352100-6352026-03-10

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08809539697376Surgical InstrumentOSTEONIC CO.,Ltd.HXP2025-06-27
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08403207010032Anmuth Medical InternationalAnmuth Medical International, LLCHXP2025-06-09
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0088823306976216mm Locking ScrewBIOMET MICROFIXATION, INCHXP2024-03-25
00888515202146BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXP2024-02-28
00810112592641TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXP2024-02-23
00810112592658TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXP2024-02-23
00810112592481TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXP2024-02-14
00840343719265GEN2SURGIX MEDICAL LLCHXP2024-01-05
00841435122581TecometTECOMET INC.HXP2023-11-30
00841435122598TecometTECOMET INC.HXP2023-11-30
00818069014100TecometTECOMET INC.HXP2023-07-31