FDA.reportPublic FDA data

CASTROVIEJO BLADE BREAKER/HOLDER

Primary DI
00192896012738
Brand
CASTROVIEJO BLADE BREAKER/HOLDER
Company
SONTEC INSTRUMENTS, INC.
Model
11-4700
Catalog number
11-4700
Device description
CASTROVIEJO BLADE BREAKER/HOLDER WITH SLIDING LOCK LONG MODEL
Published
2018-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMFKNIFE, SURGICAL
GDZHandle, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896012738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896012738001928960127381928960127380192896012738

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical instrument handle, manualA hand-held manual device designed to hold and operate a compatible ophthalmic surgical instrument tip (typically scissors, forceps). It is typically in the form of a conventional handle with a connector that secures the inserted tip, and has a manually-operated internal actuating piston that operates the inserted tip (e.g., opens and closes blades). It is typically used for surgery in the anterior or the posterior segment to cut, grasp, and manipulate eye tissue; it is not a handle for a corneal trephine. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896044661BARR PROBE508-547508-5472018-09-14
00192896123397Smithwick Vasectomy Hook516-716516-7162026-05-12
00192896123373Skinner Tissue Forceps140-376H140-376H2026-05-11
00192896123380Biopsy Punch2901-117L2901-117L2026-05-11
00192896123403Mictec High Frequency Cable26944-3226944-322026-05-11
00192896123410Biopsy Cup2901-125L2901-125L2026-05-11
00192896112193HU Capsular Polisher12-268512-26852022-02-03
00192896025929MEYERDING RETRACTOR207-411207-4112018-09-12
00192896025936MEYERDING RETRACTOR207-413207-4132018-09-12
00192896025943MEYERDING RETRACTOR207-415207-4152018-09-12
00192896100671TEALES GORGET SPECULUM516-506516-5062025-02-24
00192896118003Reynolds Tenotomy Scissors2405-329B2405-329B2024-06-21
00192896115750Teales Gorget SpeculumT516-507T516-5072023-11-03
00192896099753LUXATOR ELEVATOR1100-586S11100-586S12018-09-21
00192896015272ENUCLEATION SCISSORS13-980513-98052018-09-13
00192896015289ENUCLEATION SCISSORS13-981013-98102018-09-13
00192896015296ENUCLEATION SCISSORS13-982013-98202018-09-13
00192896017214CASTROVIEJO LIP GRAFT CLAMP FORCEPS14-972514-97252018-09-17
00192896081635LUXATOR ELEVATOR1100-586C11100-586C12018-09-21
00192896081642LUXATOR ELEVATOR1100-586C21100-586C22018-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811000040INKAThe Trustee for KAISER FAMILY TRUSTGDZ2025-11-19
10888277370647MEDLINEMEDLINE INDUSTRIES, INC.EMF2025-02-14
10888277377615MEDLINEMEDLINE INDUSTRIES, INC.EMF2025-01-21
10620974003318SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
10620974003325SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
10620974003332SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
10620974003349SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
10620974003356SPSS Safety Scalpel Metal HandleSouthmedic IncorporatedGDZ2023-02-07
G25001001030Scalpel Handle No.3N S SURGICAL COMPANYGDZ2023-01-31
G25001002040Scalpel Handle No.4N S SURGICAL COMPANYGDZ2023-01-31
07708626670395SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SGDZ2023-01-18
14026704788047PILLINGTELEFLEX INCORPORATEDGDZ2022-12-08
14026704788054PILLINGTELEFLEX INCORPORATEDGDZ2022-12-08
10888277370623MedlineMEDLINE INDUSTRIES, INC.EMF2022-05-12
10888277370630MedlineMEDLINE INDUSTRIES, INC.EMF2022-05-12
10080196652518MEDLINEMEDLINE INDUSTRIES, INC.GDZ2022-01-01
10080196652532MEDLINEMEDLINE INDUSTRIES, INC.GDZ2022-01-01
10080196652549MEDLINEMEDLINE INDUSTRIES, INC.GDZ2022-01-01
10653160275053CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGDZ2022-01-01
10653160331421CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGDZ2022-01-01
10889950002978HU-FRIEDYHU-FRIEDY MFG. CO., LLCGDZ2020-11-12
10889950014742HU-FRIEDYHU-FRIEDY MFG. CO., LLCEMF2020-11-12
10649111443060SklarSKLAR CORPORATIONEMF2019-07-29
10649111443077SklarSKLAR CORPORATIONEMF2019-07-29
10649111143793SklarSKLAR CORPORATIONEMF2019-05-13
10649111144417SklarSKLAR CORPORATIONEMF2019-05-13
10649111145315SklarSKLAR CORPORATIONEMF2019-05-13
10649111145940SklarSKLAR CORPORATIONEMF2019-05-13
10649111028212SklarSKLAR CORPORATIONEMF2019-05-07
10649111348440SklarSKLAR CORPORATIONEMF2019-05-07