FDA.reportPublic FDA data

ELAN 4

Primary DI
04046964602856
Brand
ELAN 4
Company
AESCULAP, INC.
Model
US645SU
Catalog number
US645SU
Device description
HI-LINE XS DIAMOND BURR COARSE II D0.5MM
Published
2020-10-27
Public version status
New
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
GEYMOTOR, SURGICAL INSTRUMENT, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964602856PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964602856040469646028564046964602856

GMDN Terms#

Term, Definition table
TermDefinition
Burring power tool attachmentA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a burring function when an appropriate bur is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
082594540
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964823794AESCULAPMF320MF3202026-04-18
04046964759895VEGAMG985RMG985R2020-10-16
04046964759925VEGAMG982RMG982R2020-10-16
04046964759956VEGAMG981RMG981R2020-10-16
04046964993312AESCULAPMG223RMG223R2026-01-16
04046964993329AESCULAPMG224RMG224R2026-01-16
04046955077069AESCULAPUS137US1372020-08-10
04046955077076AESCULAPUS138US1382020-08-10
04046955066544AESCULAPMG512RMG512R2020-09-26
04046955076550AESCULAPMG065RMG065R2020-09-26
04046955076611AESCULAPMG182RMG182R2020-08-25
04046964759970VEGAMG980RMG980R2020-10-16
04046955919369AESCULAPUS981SUUS981SU2025-10-31
04046955919383AESCULAPUS982SUUS982SU2025-10-31
04046955919406AESCULAPUS983SUUS983SU2025-10-31
04046955920327AESCULAPUS984SUUS984SU2025-10-31
04046955920341AESCULAPUS985SUUS985SU2025-10-31
04046955920365AESCULAPUS986SUUS986SU2025-10-31
04046955920389AESCULAPUS987SUUS987SU2025-10-31
04046955920402AESCULAPUS988SUUS988SU2025-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051471220195De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-03-24
00889024706538REDUCED ZIMMER ANT ADAPTERZimmer, Inc.GEY2026-03-19
07613327656763BPXSTRYKER CORPORATIONGEY2026-03-04
07613327656770BPXSTRYKER CORPORATIONGEY2026-03-04
07613327657760BPXSTRYKER CORPORATIONGEY2026-03-04
07613327657777BPXSTRYKER CORPORATIONGEY2026-03-04
07613327657784BPXSTRYKER CORPORATIONGEY2026-03-04
07613327657791BPXSTRYKER CORPORATIONGEY2026-03-04
07613327657814BPXSTRYKER CORPORATIONGEY2026-03-04
07613327659429BPXSTRYKER CORPORATIONGEY2026-03-04
05051471220812De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-03-02
05051471220836De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-03-02
05051471220263De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-01-29
00193982678906VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678913VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678920VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678982VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679002VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679286VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
05051471219625De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-01-05
04055207036693POWER STICK M5/0Richard Wolf GmbHGEY2025-12-18
05051471215283De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-12-04
05051471219038De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-12-04
05051471219175De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-12-04
05051471219199De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-12-04
05051471214453De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17
05051471214460De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17
05051471214477De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17
05051471214484De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17
05051471214491De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2025-09-17