FDA.reportPublic FDA data

AESCULAP

Primary DI
04046964568022
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MB585R
Catalog number
MB585R
Device description
"ROUX Wound Retractor (Double Ended), 6 1/2"", (165 mm), double ended, 29 x 40 mm, non-sterile, reusable"
Published
2020-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04046964568022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964568022040469645680224046964568022

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04046955074921AESCULAPFF829RFF829R2019-04-30
04046955074938AESCULAPFF830RFF830R2019-04-30
04046955074945AESCULAPFF831RFF831R2019-04-30
04046955074952AESCULAPFF841RFF841R2019-04-30
04046955074525AESCULAPBH189RBH189R2020-05-08
04046955075249AESCULAPMB180RMB180R2020-05-08
04046955075409AESCULAPMB272RMB272R2020-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776395483MillenniumAvalign Technologies, Inc.GAD2026-07-14
B382SD123750Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD123760Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD123780Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD124326191140Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209910FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209920FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209923FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907126105T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907247080T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907247112T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD90724711T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907249100Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907284670Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907337510Surgical DirectSurgical Direct, Inc.GAD2026-07-14
G453152901750PEAK MEDICALPeak Medical Distribution Inc.GAD2026-07-14
00198506091872ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-10
00810158211193PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00810158219861PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00888937033687ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033694ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033700ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033717ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033724ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033731ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033748ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033755ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033762ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033779ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033786ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10