FDA.reportPublic FDA data

ELAN 4

Primary DI
04046955157723
Brand
ELAN 4
Company
Aesculap AG
Model
GP587SU
Catalog number
GP587SU
Device description
DISP.SAW BLADE M TRANSVERSAL 7/11/0.7
Published
2020-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBCMOTOR, DRILL, ELECTRIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBCMotor, Drill, ElectricNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955157723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955157723040469551577234046955157723

GMDN Terms#

Term, Definition table
TermDefinition
Reciprocating surgical saw blade, single-useA sterile, flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a dedicated sternum saw blade). This device is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is powered in a rapid reciprocating movement (a back and forth motion like a jigsaw) against the object to be cut. The end of the blade is typically not protected. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
315018218
Device count
1
Lot or batch
true
Expiration date on label
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
08809260473430TRAUSSaeshin Precision Co., Ltd.HBC2026-05-20
08809260475489TRAUSSaeshin Precision Co., Ltd.HBC2026-04-01
08809260475496TRAUSSaeshin Precision Co., Ltd.HBC2026-04-01
08809260475502TRAUSSaeshin Precision Co., Ltd.HBC2026-04-01
08809260475427TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
08809260475434TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
08809260475441TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
08809260475465TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
08809260475472TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAHBC2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAHBC2025-03-21
17630055506266Bur PM2-MIS D150 steel Ø2.0 StBien-Air Surgery SAHBC2025-03-21
17630055506273Bur PM2-MIS D150 steel Ø3.0 StBien-Air Surgery SAHBC2025-03-21
17630055506280Bur PM2-MIS D150 diam Ø2.0 StBien-Air Surgery SAHBC2025-03-21
17630055506297Bur PM2-MIS D150 diam Ø3.0 StBien-Air Surgery SAHBC2025-03-21
17630055506303Bur PM2-MIS D150 Mstick Ø1.8 StBien-Air Surgery SAHBC2025-03-21
17630055506310Bur PM2-MIS D150 Mstick Ø3.0 StBien-Air Surgery SAHBC2025-03-21
17630055506327Bur PM2-MIS D150 diam C Ø3.0 StBien-Air Surgery SAHBC2025-03-21
17630055506358Bur PM2-MIS D150 steel Ø4.0 StBien-Air Surgery SAHBC2025-03-21
17630055506365Bur PM2-MIS D150 diam Ø4.0 StBien-Air Surgery SAHBC2025-03-21
17630055506525High-Speed Micro-Motor, smallBien-Air Surgery SAHBC2023-03-17
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAHBC2023-02-22
07630055507792Cable for Perforator MotorBien-Air Surgery SAHBC2023-02-22
07630055507815High-Speed Micro-Motor without cableBien-Air Surgery SAHBC2023-02-22
07630055507822Cable for HS-Micro-Motor,smallBien-Air Surgery SAHBC2023-02-22