FDA.reportPublic FDA data

AESCULAP

Primary DI
04046964498756
Brand
AESCULAP
Company
Aesculap AG
Model
GA395SU
Catalog number
GA395SU
Device description
ELAN 4 ELECTRO DISPOSABLE TUBE SET
Published
2016-11-25
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
04046964498756PrimaryGS10
04046963894559Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964498756040469644987564046964498756
04046963894559040469638945594046963894559

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. 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
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964680878COREHIP EXTENDEDNK1126TNK1126T2020-08-10
04046964681028COREHIP EXTENDEDNK1131TNK1131T2020-08-10
04046964681127COREHIP PRIMARYNK1201KNK1201K2020-08-10
04046964681189COREHIP PRIMARYNK1207KNK1207K2020-08-10
04046964681301COREHIP PRIMARYNK1209KNK1209K2020-08-10
04046964681349COREHIP PRIMARYNK1221KNK1221K2020-08-10
04046964681363COREHIP PRIMARYNK1223KNK1223K2020-08-10
04046964681387COREHIP PRIMARYNK1225KNK1225K2020-08-10
04046964681400COREHIP PRIMARYNK1227KNK1227K2020-08-10
04046964681424COREHIP PRIMARYNK1229KNK1229K2020-08-10
04046964681462COREHIP PRIMARYNK1241KNK1241K2020-08-10
04046964681486COREHIP PRIMARYNK1243KNK1243K2020-08-10
04046964681509COREHIP PRIMARYNK1245KNK1245K2020-08-10
04046964681523COREHIP PRIMARYNK1247KNK1247K2020-08-10
04046964681547COREHIP PRIMARYNK1249KNK1249K2020-08-10
04046963929435NOVOCARTFR719RFR719R2020-08-24
04046963933357NOVOCARTFR651RFR651R2020-08-24
04038653289509NOVOCARTFR661RFR661R2020-08-10
04046963565992NOVOCARTFR660SUFR660SU2020-04-24
04046963939588NOVOCARTFR744RFR744R2020-04-24

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