FDA.reportPublic FDA data

AESCULAP

Primary DI
04046964587276
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MA442R
Catalog number
MA442R
Device description
"KERRISON Rongeur, 90 °, angled upwards, 6"" (150 mm), jaw length: 5 mm, #3"
Published
2020-05-07
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
KBBRONGEUR, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBBRongeur, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964587276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964587276040469645872764046964587276

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. 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
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09348811112484INKAThe Trustee for KAISER FAMILY TRUSTKBB2026-01-28
09348811146052INKAThe Trustee for KAISER FAMILY TRUSTKBB2025-12-01
09348811172921INKAThe Trustee for KAISER FAMILY TRUSTKBB2025-12-01
09348811145970INKAThe Trustee for KAISER FAMILY TRUSTKBB2025-11-27
09348811172914INKAThe Trustee for KAISER FAMILY TRUSTKBB2025-11-27
00757770404759Bausch + LombBausch & Lomb IncorporatedKBB2025-07-31
00757770407071Bausch + LombBausch & Lomb IncorporatedKBB2025-07-31
00757770411979Bausch + LombBausch & Lomb IncorporatedKBB2025-07-31
00757770425396Bausch + LombBausch & Lomb IncorporatedKBB2025-07-30
00757770428632Bausch + LombBausch & Lomb IncorporatedKBB2025-07-30
00757770430925Bausch + LombBausch & Lomb IncorporatedKBB2025-07-30
00757770469475Bausch + LombBausch & Lomb IncorporatedKBB2025-07-30
00190776407056MillenniumAvalign Technologies, Inc.KBB2025-07-28
08403207006042Anmuth Medical InternationalAnmuth Medical International, LLCKBB2025-01-24
08403207006059Anmuth Medical InternationalAnmuth Medical International, LLCKBB2025-01-24
00842331191404Novo SurgicalNOVO SURGICAL, INC.KBB2023-12-18
G586E7373630Novo SurgicalNOVO SURGICAL, INC.KBB2023-12-18
00190776044817AvalignAvalign Technologies, Inc.KBB2023-11-13
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00190776044824AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776044831AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776044848AvalignAvalign Technologies, Inc.KBB2023-09-28
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00190776221102AvalignAvalign Technologies, Inc.KBB2023-09-28
00190776320492MILLENNIUMAvalign Technologies, Inc.KBB2023-09-28
00190776320508MILLENNIUMAvalign Technologies, Inc.KBB2023-09-28