FDA.reportPublic FDA data

AESCULAP

Primary DI
04046964572326
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MF425R
Catalog number
MF425R
Device description
"JANNETTA Fork, 30 °, angled, 7 1/2"", (190 mm), 2 prongs, #13, width: 1,400 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
JYLHOOK, MICROSURGICAL EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYLHook, Microsurgical EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964572326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964572326040469645723264046964572326

GMDN Terms#

Term, Definition table
TermDefinition
Ear spoonA hand-held manual surgical instrument intended to be used during interventions in the ear to remove or manipulate tissue or anatomical structures. It is usually made of high-grade stainless steel and has a cylindrical handle located centrally from which a shaft protrudes in both directions. These shafts terminate with an operative instrument, one of which is spoon-shaped. The opposite tip may be, e.g., blunt or pointed and possibly at a right angle to the shaft. 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
true
Premarket exempt
true
Lot or batch
true
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
04054462911585evonosevonos GmbH & Co. KGJYL2026-08-19
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04054462906741evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906758evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906789evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906802evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906925evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906932evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906949evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906956evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906963evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906970evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906987evonosevonos GmbH & Co. KGJYL2026-08-18
04054462906994evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907007evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907014evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907021evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907038evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907045evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907052evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907076evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907083evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907090evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907106evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907120evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907151evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907168evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907175evonosevonos GmbH & Co. KGJYL2026-08-18
04054462907182evonosevonos GmbH & Co. KGJYL2026-08-18