FDA.reportPublic FDA data

AESCULAP

Primary DI
04046955076772
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MG511R
Catalog number
MG511R
Device description
TILTING & SWIVELING BLADE CLAMP
Published
2020-09-26
Public version status
Update
Distribution status
Not 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
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955076772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955076772040469550767724046955076772

GMDN Terms#

Term, Definition table
TermDefinition
Bone approximation clampA hand-held manual surgical instrument designed to grip and hold a bone or, being used in pairs one on either side of the fracture, to approximate the proximal and distal segment of a fractured bone during orthopaedic surgery. It is typically made of high-grade stainless steel and is designed with a double hooked, blade-like jaw at the distal end (this hooks over the upper edge of the bone) whilst an adjustable single hook is tightened against the lower edge of the bone through a screw mechanism. A traction bar may be employed to bridge the two bone clamps and using its screw mechanism, the fracture is drawn together. 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
082594540
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
04046955066742AESCULAPMG714RMG714R2020-05-08
04046964683978AESCULAPMG090RMG090R2020-09-21
04046964587368AESCULAPMA456RMA456R2020-05-08
04046964676628AESCULAPUS399US3992016-09-22
04046964256967AESCULAPUS910US9102016-09-22
05055049000608AESCULAPUS905US9052016-09-22
05055049007423AESCULAPUS906US9062016-09-22
04046955074624AESCULAPFF025RFF025R2019-04-30
04046955074631AESCULAPFF026RFF026R2019-04-30
04046955074648AESCULAPFF027RFF027R2019-04-30
04046955074655AESCULAPFF028RFF028R2019-04-30
04046955074662AESCULAPFF029RFF029R2019-04-30
04046955074716AESCULAPFF086RFF086R2019-04-30
04046955074723AESCULAPFF087RFF087R2019-04-30
04046955074730AESCULAPFF088RFF088R2019-04-30
04046955074792AESCULAPFF136RFF136R2019-04-30
04046955074808AESCULAPFF137RFF137R2019-04-30
04046955074815AESCULAPFF138RFF138R2019-04-30
04046955074822AESCULAPFF690RFF690R2019-04-30
04046955074914AESCULAPFF828RFF828R2019-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435578MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776435585MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776437787MillenniumAvalign Technologies, Inc.GAD2026-10-20
00190776439699MilleniumAvalign Technologies, Inc.GAD2026-10-20
B382SD907310070Surgical DirectSurgical Direct, Inc.GAD2026-10-20
00190776435219MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435233MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435264MillenniumAvalign Technologies, Inc.GAD2026-10-19
00190776435301MillenniumAvalign Technologies, Inc.GAD2026-10-19
03661219011590LANDANGERLANDANGERGAD2026-10-19
G4533310960PEAK MEDICALPeak Medical Distribution Inc.GAD2026-10-19
00198506056529ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096075ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096082ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00198506096099ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-16
00810111228480RetractorTreace Medical Concepts, Inc.GAD2026-10-16
00724995266936Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
00810130207572MSIModern Surgical Instruments LLCGAD2026-10-15
00810130207589MSIModern Surgical Instruments LLCGAD2026-10-15
00810220800645Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800652Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800669Adler Instrument CompanyAdler, Inc.GAD2026-10-15
03661219013341LANDANGERLANDANGERGAD2026-10-15
10724995269316Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
10724995269323Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
00190776434953MillenniumAvalign Technologies, Inc.GAD2026-10-14
00192896123922Knurled NutSONTEC INSTRUMENTS, INC.GAD2026-10-14
00842102116513DynaTrac Retractor FramesFLEXBAR MACHINE CORPORATIONGAD2026-10-14
00190776434632MillenniumAvalign Technologies, Inc.GAD2026-10-12
00190776434663MillenniumAvalign Technologies, Inc.GAD2026-10-12