FDA.reportPublic FDA data

AESCULAP

Primary DI
04046964584695
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MA182R
Catalog number
MA182R
Device description
DAY EAR HK LRG ANG 90DEG 159MM
Published
2020-05-07
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
04046964584695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964584695040469645846954046964584695

GMDN Terms#

Term, Definition table
TermDefinition
ENT elevatorA hand-held, manually-operated, surgical instrument used to lift, position or pry anatomical structures or surgical material during ear/nose/throat (ENT) surgery. It may be a single or a double-ended device with a blunted blade or hook of various shapes with no cutting edges at the distal working end(s) and a handle positioned centrally or at the proximal end. Its shape and size depends upon the intended use, e.g., a blunt antrum, a rhinology or septum elevator, a strong nasal fracture elevator, or a specially designed ear elevator. It is usually made of high-grade stainless steel. 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
G043615080BEARBear-Ent, LLCJYL2026-01-19
G043615090BEARBear-Ent, LLCJYL2026-01-19
G043615100BEARBear-Ent, LLCJYL2026-01-19
09348811108364INKAThe Trustee for KAISER FAMILY TRUSTJYL2025-12-02
09348811149886INKAThe Trustee for KAISER FAMILY TRUSTJYL2025-12-02
04250676734891MENTIO disposable ear curette cottonSpiggle & Theis Medizintechnik GmbHJYL2025-10-07
04250676734907MENTIO Disposable Nasal SpeculaSpiggle & Theis Medizintechnik GmbHJYL2025-10-07
04250381821503Gillies skin hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-29
04250676710017HookSpiggle & Theis Medizintechnik GmbHJYL2025-09-29
04250676711625ForkSpiggle & Theis Medizintechnik GmbHJYL2025-09-29
04250676705259Herberhold osteotome for lateralSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676705266Herberhold osteotome for lateralSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676716071Herberhold osteotomeSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676716088Herberhold osteotomeSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676738394HookSpiggle & Theis Medizintechnik GmbHJYL2025-09-09
04250676735560Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735577Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735584Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735591Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676735607Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739582Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739599Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739605Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739612Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676739629Wagener cerumen hookSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
04250676745248Universal scissorsSpiggle & Theis Medizintechnik GmbHJYL2025-09-03
00757770406265Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05
00757770406371Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05
00757770410125Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05
00757770412631Bausch + LombBausch & Lomb IncorporatedJYL2025-08-05