FDA.reportPublic FDA data

Stem Broach 7.5MM

Primary DI
M209194600
Brand
Stem Broach 7.5MM
Company
BIOPRO, INC.
Model
19460
Published
2019-05-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTQBroach

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTQBroachOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M209194600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Microwave Radiation

Regulatory Flags#

DUNS number
618749857
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M209232580Hintermann Compressor232582026-05-22
M209232590Hintermann Distractor232592026-05-22
M20918608010mm HBS® Standard Compression186082015-09-16
M20918609011mm HBS® Standard Compression186092015-09-16
M20918610012mm HBS® Standard Compression186102015-09-16
M20918611013mm HBS® Standard Compression186112015-09-16
M20918612014mm HBS® Standard Compression186122015-09-16
M20918613015mm HBS® Standard Compression186132015-09-16
M20918614016mm HBS® Standard Compression186142015-09-16
M20918615017mm HBS® Standard Compression186152015-09-16
M20918616018mm HBS® Standard Compression186162015-09-16
M20918617019mm HBS® Standard Compression186172015-09-16
M20918618020mm HBS® Standard Compression186182015-09-16
M20918619021mm HBS® Standard Compression186192015-09-16
M20918620022mm HBS® Standard Compression186202015-09-16
M20918621023mm HBS® Standard Compression186212015-09-16
M20918622024mm HBS® Standard Compression186222015-09-16
M20918623025mm HBS® Standard Compression186232015-09-16
M20918624026mm HBS® Standard Compression186242015-09-16
M20918625027mm HBS® Standard Compression186252015-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295079965AML EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080176EXCEL TRI-LOCKDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080183EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080190EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080206EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080213EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080220EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080237EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080244EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080251NADEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080268NADEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080275EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080282EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080299EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080305EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080312EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080329EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080336EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080343NADEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080350NADEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080367EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080374EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295080381EXCELDEPUY ORTHOPAEDICS, INC.HTQ2018-09-24
10603295082057TRI-LOCKDEPUY (IRELAND)HTQ2018-09-24
10603295082064TRI-LOCKDEPUY (IRELAND)HTQ2018-09-24
10603295082071TRI-LOCKDEPUY (IRELAND)HTQ2018-09-24
10603295082088TRI-LOCKDEPUY (IRELAND)HTQ2018-09-24
10603295082095TRI-LOCKDEPUY (IRELAND)HTQ2018-09-24
10603295082101TRI-LOCKDEPUY (IRELAND)HTQ2018-09-24
10603295082118TRI-LOCKDEPUY (IRELAND)HTQ2018-09-24