FDA.reportPublic FDA data

Stone Instruments Co

Primary DI
G426TI02000
Brand
Stone Instruments Co
Company
STONE INSTRUMENTS CO
Model
TI-0200
Catalog number
TI-0200
Device description
McCulloch Type Hinged Retractor
Published
2026-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G426TI02000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
645446428
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G426SI10410IN-SITU ROD BENDER SI-10412023-03-09
G426SI10460ROD BENDER SI-10462023-03-09
G426SI10500ROD FORK SI-10502023-03-09
G426STNKLTR0614240PLATE HOLDING FORCEPSKLTR0614242024-08-20
G426KLTR032223PF0PLATE HOLDING FORCEPSKLTR032223PF 2023-04-29
G426KLTR032223V010PLATE HOLDING FORCEPSKLTR032223V01 2023-04-29
G426SI10010SPREADER SI-10012023-03-09
G426SI10060COMPRESSOR SI-10062023-03-09
G426SI10230ROD HOLDER SI-10232023-03-09
G426SI1023CA0ROD HOLDER SI-1023-CA2023-03-09
G426SI10380ROD CUTTER SI-10382023-03-09
G426SI10860EGG HANDLE RATCHET SI-10862023-03-09
G426SI11740T HANDLE RATCHETSI-11742023-03-09
G426KLTR030422L0STONE INSTRUMENTS CO KL-TR030422-L2023-02-22
G426KLTR030422M0STONE INSTRUMENTS CO KL-TR030422-M2023-02-21

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