FDA.reportPublic FDA data

Chisel

Primary DI
04054896005751
Brand
Chisel
Company
Silony Medical GmbH
Model
RI-1510
Catalog number
RI-1510
Device description
ROCCIA Chisel 10 mm Width Angled 25°
Published
2026-09-18
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

Product Codes#

Code, Name table
CodeName
FZOCHISEL, SURGICAL, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZOChisel, Surgical, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054896005751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054896005751040548960057514054896005751

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
342538826
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04054896000770AwlVI-1010VI-10102026-09-18
04054896000787AwlVI-1020VI-10202026-09-18
04054896000831Control GaugesVI-1040VI-10402026-09-18
04054896000855Implant ModifierVI-1160VI-11602026-09-18
04054896000862Implant ModifierVI-1250VI-12502026-09-18
04054896000879Implant ModifierVI-1270VI-12702026-09-18
04054896000886Forceps and ClampsVI-1320VI-13202026-09-18
04054896000893(Re-) Positioning ToolsVI-1340VI-13402026-09-18
04054896000909(Re-) Positioning ToolsVI-1360VI-13602026-09-18
04054896000916(Re-) Positioning ToolsVI-1361VI-13612026-09-18
04054896000923AdapterVI-1362VI-13622026-09-18
04054896000930(Re-) Positioning ToolsVI-1363VI-13632026-09-18
04054896000947AdapterVI-1410VI-14102026-09-18
04054896000985Torque LimiterVI-1450VI-14502026-09-18
04054896000992(Re-) Positioning ToolsVI-1510VI-15102026-09-18
04054896001005Forceps and ClampsVI-1530VI-15302026-09-18
04054896001012Implant ModifierVI-1610VI-16102026-09-18
04054896001029Forceps and ClampsVI-1620VI-16202026-09-18
04054896001036Forceps and ClampsVI-1630VI-16302026-09-18
04054896001067Forceps and ClampsVI-1820VI-18202026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054896001753ChiselSilony Medical GmbHFZO2026-09-18
04054896001760ChiselSilony Medical GmbHFZO2026-09-18
04054896001777ChiselSilony Medical GmbHFZO2026-09-18
04054896018430ChiselSilony Medical GmbHFZO2026-09-18
04054896018447ChiselSilony Medical GmbHFZO2026-09-18
04054896050652ChiselSilony Medical GmbHFZO2026-09-18
04054896050669ChiselSilony Medical GmbHFZO2026-09-18
04054896050676ChiselSilony Medical GmbHFZO2026-09-18
04054896050683ChiselSilony Medical GmbHFZO2026-09-18
04054896050690ChiselSilony Medical GmbHFZO2026-09-18
04054896050706ChiselSilony Medical GmbHFZO2026-09-18
04054896051284ChiselSilony Medical GmbHFZO2026-09-18
04054462907663evonosevonos GmbH & Co. KGFZO2026-08-21
04054462912162evonosevonos GmbH & Co. KGFZO2026-08-19
04054462912179evonosevonos GmbH & Co. KGFZO2026-08-19
04054462912803evonosevonos GmbH & Co. KGFZO2026-08-19
04054462912810evonosevonos GmbH & Co. KGFZO2026-08-19
04054462905416evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905423evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905430evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905447evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905461evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905478evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905485evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905492evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905508evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905515evonosevonos GmbH & Co. KGFZO2026-08-18
04054462905522evonosevonos GmbH & Co. KGFZO2026-08-18
04054462907632evonosevonos GmbH & Co. KGFZO2026-08-18
04054462907649evonosevonos GmbH & Co. KGFZO2026-08-18