FDA.reportPublic FDA data

ELAN 4

Primary DI
04046964726194
Brand
ELAN 4
Company
Aesculap AG
Model
GB925R
Catalog number
GB925R
Device description
ELAN 4 MIS HANDPIECE SHAFT L13 STRAIGHT
Published
2019-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBBMOTOR, DRILL, PNEUMATIC
HBCMOTOR, DRILL, ELECTRIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBBMotor, Drill, PneumaticNeurology2
HBCMotor, Drill, ElectricNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964726194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964726194040469647261944046964726194

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, reusableA device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
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
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000521622MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-08-10
00763000722326ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-25
00763000722340ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBC2025-07-25
00763000722333ENT MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBC2025-07-25
00763000722357MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBC2025-07-25
00763000722425MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBC2025-07-21
00763000988791Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-07-17
08809260473669SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260473676SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260473713SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260473942SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260473980SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260474017SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260474697SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260474727SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260474987SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260474994SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
08809260475038SSG10Saeshin Precision Co., Ltd.HBC2025-05-21
00721902573613MIDAS REXMEDTRONIC POWERED SURGICAL SOLUTIONSHBC2025-03-27
07630055508072PM2-S MISBien-Air Surgery SAHBC2025-03-21
17630055508093PM2-Nose MIS D150Bien-Air Surgery SAHBC2025-03-21
17630055512601PM2-Nose MIS P160Bien-Air Surgery SAHBC2025-03-21
00763000521813MIDAS REX LEGENDMEDTRONIC POWERED SURGICAL SOLUTIONSHBB2025-03-20
07630055508065PM2-A MISBien-Air Surgery SAHBC2025-03-20
04560264529243Primado2NAKANISHI INC.HBC2025-01-22
04560264529250Primado2NAKANISHI INC.HBC2025-01-22
17630055513820Bur Cranial Spiral 25mm StBien-Air Surgery SAHBC2024-12-04
17630055515664Bur PM2-150 80K Diam Ø4.0 StBien-Air Surgery SAHBC2024-12-04
17630055515671Bur PM2-150 80K Diam Ø3.1 StBien-Air Surgery SAHBC2024-12-04
17630055515688Bur PM2-150 80K Diam Ø1.8 StBien-Air Surgery SAHBC2024-12-04