FDA.reportPublic FDA data

AESCULAP

Primary DI
04046964580642
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MA028R
Catalog number
MA028R
Device description
HOUSE ALLIGATOR AND CRMPER FCPS 130MM
Published
2020-05-06
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
NNNCRIMPER, WIRE, ENT, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNNCrimper, Wire, Ent, Non-SterileEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964580642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964580642040469645806424046964580642

GMDN Terms#

Term, Definition table
TermDefinition
ENT wire crimperA hand-held manual surgical instrument designed to bend wire directly in the cavities of the ears, nose, or throat. It is typically a straight or curved forceps-like instrument with a terminal end appropriately configured to manipulate wires in the cavities of the ears, nose, or throat. 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
00194613028862MSI Precision Specialty InstrumentsMed Saver, Inc.NNN2025-08-01
00840183527457BR Surgical, LLCBR Surgical, LLCNNN2024-11-26
00888515227378BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.NNN2024-02-28
00842331191398Novo SurgicalNOVO SURGICAL, INC.NNN2023-12-18
G586E7212440Novo SurgicalNOVO SURGICAL, INC.NNN2023-12-18
G586E7212450Novo SurgicalNOVO SURGICAL, INC.NNN2023-12-18
00190776318871MillenniumAvalign Technologies, Inc.NNN2023-11-13
00190776043605AvalignAvalign Technologies, Inc.NNN2023-09-28
00190776318826MILLENNIUMAvalign Technologies, Inc.NNN2023-09-28
00190776318840MILLENNIUMAvalign Technologies, Inc.NNN2023-09-28
14026704804228PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
14026704804235PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
14026704804273PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
54026704804233PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
54026704804226PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
54026704804271PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
00842331174704Novo Surgical Inc. NOVO SURGICAL, INC.NNN2022-11-14
00842331177682Novo Surgical Inc. NOVO SURGICAL, INC.NNN2022-11-14
00842331186219Novo Surgical Inc. NOVO SURGICAL, INC.NNN2022-11-14
00842331146206Novo Surgical Inc. NOVO SURGICAL, INC.NNN2022-11-11
00887482112908Symmetry HouseASPEN SURGICAL PRODUCTS, INC.NNN2022-09-28
00887482113004Symmetry ScheerASPEN SURGICAL PRODUCTS, INC.NNN2022-09-28
00190776043575AvalignAvalign Technologies, Inc.NNN2021-11-03
00190776043582AvalignAvalign Technologies, Inc.NNN2021-11-03
00190776043612AvalignAvalign Technologies, Inc.NNN2021-11-03
00190776188658MillenniumAvalign Technologies, Inc.NNN2021-11-01
00190660056643Ambler SurgicalAMBLER SURGICAL CORP.NNN2021-01-07
00190660063733Ambler SurgicalAMBLER SURGICAL CORP.NNN2021-01-07
00190660063740Ambler SurgicalAMBLER SURGICAL CORP.NNN2021-01-07
00190660072605Ambler SurgicalAMBLER SURGICAL CORP.NNN2021-01-07