FDA.reportPublic FDA data

McIlwraith Bistouri Knife

Primary DI
00192896122796
Brand
McIlwraith Bistouri Knife
Company
SONTEC INSTRUMENTS, INC.
Model
1271-155Q
Catalog number
1271-155Q
Device description
McIlwraith Bistouri Knife Button Ended Curved 55 Millimeter Blades Quantum
Published
2026-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTSKNIFE, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTSKnife, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896122796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896122796001928961227961928961227960192896122796

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotome blade, reusableA sharp component of an orthopaedic osteotome intended to be attached to a dedicated handle (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is typically flat or curved (concave) in design and bevelled on one or both sides; it is made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Inch

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

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00192896123878Allis Tissue Forceps140-331Q140-331Q2026-10-14
00192896123885Allis Tissue Forceps140-330AQ140-330AQ2026-10-14
00192896123892Ceramitec Debakey Forceps2200-168CL2200-168CL2026-10-14
00192896123908Debakey Forceps2200-168L2200-168L2026-10-14
00192896123915Ceramitec Debakey Forceps2200-172CL2200-172CL2026-10-14
00192896123922Knurled Nut2500-200-1B2500-200-1B2026-10-14
00192896123939Bishop Harmon Tissue Forceps14-380114-38012026-10-14
00192896097049Laparoscopic Bulldog Clamp Forceps2901-2812901-2812019-05-09
00192896097056Laparoscopic Bulldog Clamp2901-281-252901-281-252019-05-09
00192896097063Laparoscopic Bulldog Clamp2901-281-402901-281-402019-05-09
00192896123793Adson Tissue Forceps140-302DLQ140-302DLQ2026-10-06
00192896123809Micro Skinner Forceps140-519M140-519M2026-10-06
00192896123816Jacobson Needle Holder2300-142D2300-142D2026-10-06
00192896123823Thumb Dressing Forceps136-610Q136-610Q2026-10-06
00192896123830Thumb Dressing Forceps136-615Q136-615Q2026-10-06
00192896123847Thumb Dressing Forceps136-619Q136-619Q2026-10-06
00192896123854Gum Scissors475-153Q475-153Q2026-10-06
00192896111394Laparoscopic Bulldog Clamp2901-281-60T2901-281-60T2021-10-22
00192896056282ALLIGATOR FORCEPS1271-0101271-0102018-09-27

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Primary DI, Brand, Company table
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20653405990403Infinity™Conmed CorporationHTS2026-06-10
20653405990410Infinity™Conmed CorporationHTS2026-06-10
00853508002645BE-ST Sheathed Bayonet Surgical Knife Lacey Manufacturing Company, LLCHTS2026-03-02
00853508002539BE-ST Sheathed Bayonet Surgical Knife Lacey Manufacturing Company, LLCHTS2026-02-16
00840967154527SigmaALPHATEC SPINE, INC.HTS2025-07-23
00192896121560Arthroscopic Bayonet KnifeSONTEC INSTRUMENTS, INC.HTS2025-05-14
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