FDA.reportPublic FDA data

AESCULAP

Primary DI
04046963450588
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MB048R
Catalog number
MB048R
Device description
"ROSS Aortic Valve Retractor, 9 5/8"", (245 mm), Fig. 2, 23 x 13 mm, non-sterile, reusable"
Published
2020-05-08
Public version status
Update
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
04046963450588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963450588040469634505884046963450588

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
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
04046955074921AESCULAPFF829RFF829R2019-04-30
04046955074938AESCULAPFF830RFF830R2019-04-30
04046955074945AESCULAPFF831RFF831R2019-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400620MillenniumAvalign Technologies, Inc.GAD2026-07-19
00190776400330MillenniumAvalign Technologies, Inc.GAD2026-07-17
00190776400361MillenniumAvalign Technologies, Inc.GAD2026-07-17
00190776400453MillenniumAvalign Technologies, Inc.GAD2026-07-17
00198506039072ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092152ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092190ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092206ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092213ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092220ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092237ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092244ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092251ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092268ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092275ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092282ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092299ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092305ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092312ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092329ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092336ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00198506092626ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-17
00810220800454Adler Instrument CompanyAdler, Inc.GAD2026-07-17
04058749048186NAFehling Instruments GmbH & Co. KGGAD2026-07-17
04058749049800NAFehling Instruments GmbH & Co. KGGAD2026-07-17
04058749078008NAFehling Instruments GmbH & Co. KGGAD2026-07-17
B382SD907808200Surgical DirectSurgical Direct, Inc.GAD2026-07-17
B382SD907808210Surgical DirectSurgical Direct, Inc.GAD2026-07-17
B382SD9079001010Surgical DirectSurgical Direct, Inc.GAD2026-07-17
B382SD97247105T0Surgical DirectSurgical Direct, Inc.GAD2026-07-17