FDA.reportPublic FDA data

AESCULAP

Primary DI
04046964589386
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MA703R
Catalog number
MA703R
Device description
"DERLACKI Ossicle Holding Clamp, 5"", (125 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
JYFCLAMP, OSSICLE HOLDING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYFClamp, Ossicle HoldingEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964589386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964589386040469645893864046964589386

GMDN Terms#

Term, Definition table
TermDefinition
Otologic clampA hand-held manual surgical instrument designed to grasp internal ear structures (e.g., a bone of the ossicles) during an ear/nose/throat (ENT) procedure. It typically has a self-retaining, scissors-like design with ring handles and is made of high-grade stainless steel. It is available in various sizes and blade designs that may utilize carbide inserts. 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
00757770417766Bausch + LombBausch & Lomb IncorporatedJYF2025-08-08
00840183524562BR Surgical, LLCBR Surgical, LLCJYF2024-05-28
G586E7216220Novo SurgicalNOVO SURGICAL, INC.JYF2023-12-18
G586E7216230Novo SurgicalNOVO SURGICAL, INC.JYF2023-12-18
00190776318925MillenniumAvalign Technologies, Inc.JYF2023-06-23
14026704805621PILLINGTELEFLEX INCORPORATEDJYF2022-12-08
54026704805629PILLINGTELEFLEX INCORPORATEDJYF2022-12-08
00887482043752Symmetry SheehyASPEN SURGICAL PRODUCTS, INC.JYF2022-09-28
00887482114407Symmetry DerlackiASPEN SURGICAL PRODUCTS, INC.JYF2022-09-28
00190660014919Ambler SurgicalAMBLER SURGICAL CORP.JYF2021-01-07
00190660017767Ambler SurgicalAMBLER SURGICAL CORP.JYF2021-01-07
M63334170280JEDMEDJEDMED INSTRUMENT COMPANYJYF2020-09-01
04046964588204AESCULAPAESCULAP, INC.JYF2020-05-08
10381780081258Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-10-24
10381780081265Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-10-24
10381780074564Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-09-17
10885403012242V. MuellerSTERIS CORPORATIONJYF2018-08-02
10381780190165Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-04-03
M2743854401Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-04-03
10381780458333Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-03-02
M2743854301Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJYF2018-03-02