FDA.reportPublic FDA data

Hintermann Series

Primary DI
B095319798
Brand
Hintermann Series
Company
Dt Medtech, LLC
Model
319798
Catalog number
319798
Device description
Flat Cut Talar Trial, Left, Size 4 Instrument
Published
2018-10-16
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B095319798PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ankle prosthesis trial, reusableA copy of a final prosthesis designed to be used during ankle replacement surgery to determine the correct alignment, size, and fit of the final tibial, talar or bearing prosthesis component. It is one of a set, or a set, of graduated sizes and is typically made of synthetic polymer or metal material. This is a reusable device.

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
B095319797Hintermann Series3197973197972018-10-16
B095322216Hintermann Series H23222163222162018-03-19
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
B095300209Hintermann Series H33002093002092019-08-19
B095300405Hintermann Series H33004053004052019-08-19
B095301113Hintermann Series H33011133011132019-08-19
B095301114Hintermann Series H33011143011142019-08-19
B095301115Hintermann Series H33011153011152019-08-19
B095302113Hintermann Series H33021133021132019-08-20
B095302125Hintermann Series H33021253021252019-08-20

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00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17
00840314264541gSourceGSOURCE LLCLXH2026-07-17
00840314264619gSourceGSOURCE LLCLXH2026-07-17
00840314264688gSourceGSOURCE LLCLXH2026-07-17