FDA.reportPublic FDA data

AESCULAP

Primary DI
04046964583919
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MA143R
Catalog number
MA143R
Device description
"OBWEGESER-FREER Elevator, 8 1/2"", (215 mm), double ended, blunt/blunt, 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
EMJELEVATOR, SURGICAL, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964583919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964583919040469645839194046964583919

GMDN Terms#

Term, Definition table
TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery (e.g., dental, orthopaedic), including use on the ribs. In dentistry it may be used to access retained roots, or for their removal with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
00190776395506MillenniumAvalign Technologies, Inc.EMJ2026-07-14
00190776395513MillenniumAvalign Technologies, Inc.EMJ2026-07-14
00190776395544MillenniumAvalign Technologies, Inc.EMJ2026-07-14
00190776395551MillenniumAvalign Technologies, Inc.EMJ2026-07-14
00190776395377MillenniumAvalign Technologies, Inc.EMJ2026-07-13
00850083275549Intrace USAPILOTIS TECH LLCEMJ2026-07-03
00810189451216Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451223Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451230Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451247Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451254Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451261Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451278Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451285Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451292Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451308Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451315Surgical DesignSurgical Design, Inc.EMJ2026-06-06
G149TBSB7540TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7550TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7560TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7570TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7580TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7590TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7600TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7610TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7620TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7630TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7640TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7650TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7660TBS BASICSACME ENTERPRISE.EMJ2026-05-21