FDA.reportPublic FDA data

SQ.LINE

Primary DI
04046955288847
Brand
SQ.LINE
Company
Aesculap AG
Model
FL418NR
Catalog number
FL418NR
Device description
GOUGE W/HANDLE 30MM 240MM
Published
2020-08-10
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
GDHGOUGE, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDHGouge, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955288847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955288847040469552888474046955288847

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
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
04038653033997AESCULAPDC230RDC230R2020-06-17
04038653034321AESCULAPDE112RDE112R2020-06-17
04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
04038653034901AESCULAPDE676RDE676R2020-06-17
04046963116194S4 CERVICALFW028UFW028U2020-08-24
04046963794248ELAN 4GA768GA7682020-04-24
04046963935184HI-LINE XXSGE813SUGE813SU2020-04-24
04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
04046964076664AESCULAPGE812SUGE812SU2020-04-24
04046964526213ECCOSGB068RGB068R2020-04-24
04038653013845AESCULAPOP297ROP297R2017-07-31
04038653081141AESCULAPOP913OP9132016-09-23
04038653081158AESCULAPOP914OP9142020-08-10
04038653013852AESCULAPOP298ROP298R2020-04-17
04046963730109AESCULAPOP923OP9232019-04-30
04046955273508AICONJJ612JJ6122022-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07898506848232QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848249QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848287QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848294QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848317QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848324QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506850259QuinelatoSchobell Industrial LtdaGDH2023-01-10
07898506848256QuinelatoSchobell Industrial LtdaGDH2022-12-16
07898506848263QuinelatoSchobell Industrial LtdaGDH2022-12-16
10603295083375SIGMADEPUY (IRELAND)GDH2018-09-24
10381780184584Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-09-12
10381780184607Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-09-12
10381780221128Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-09-12
10381780363071Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-08-16
10381780405603Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-08-16
10381780403357Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780403364Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780403371Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780403388Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780403425Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780403432Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780405689Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780406983Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10381780408598Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDH2018-05-03
10649111030956Sklar®SKLAR CORPORATIONGDH2018-04-23
10649111031045Sklar®SKLAR CORPORATIONGDH2018-04-23
10649111031939Sklar®SKLAR CORPORATIONGDH2018-04-23
10649111037474Sklar®SKLAR CORPORATIONGDH2018-04-23
10649111037610Sklar®SKLAR CORPORATIONGDH2018-04-23