FDA.reportPublic FDA data

Hintermann Series

Primary DI
B095319375
Brand
Hintermann Series
Company
Dt Medtech, LLC
Model
319375
Catalog number
319375
Device description
Talar Cut Guide Left - Size 5 Instrument
Published
2018-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B095319375PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guide, reusableA surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-521-5002quality@dtmedtech.com

Regulatory Flags#

DUNS number
080101891
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B095129681Hintermann Series1296811296812018-10-16
B095129682Hintermann Series1296821296822018-10-16
B095129696Hintermann Series1296961296962018-10-16
B095129680Hintermann Series1296801296802018-10-16
B095129683Hintermann Series1296831296832018-10-16
B095129684Hintermann Series1296841296842018-10-16
B095129685Hintermann Series1296851296852018-10-16
B095129686Hintermann Series1296861296862018-10-16
B095129690Hintermann Series1296901296902018-10-16
B095129691Hintermann Series1296911296912018-10-16
B095129692Hintermann Series1296921296922018-10-16
B095129693Hintermann Series1296931296932018-10-16
B095129694Hintermann Series1296941296942018-10-16
B095129695Hintermann Series1296951296952018-10-16
B095319869Hintermann Series3198693198692021-01-15
B095309630Hintermann Series3096303096302018-10-04
B095319680Hintermann Series3196803196802018-10-16
B095319681Hintermann Series3196813196812018-10-16
B095319682Hintermann Series3196823196822018-10-16
B095319683Hintermann Series3196833196832018-10-16

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Primary DI, Brand, Company table
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