FDA.reportPublic FDA data

Hintermann Series

Primary DI
B095319661
Brand
Hintermann Series
Company
Dt Medtech, LLC
Model
1
Catalog number
319661
Device description
PE Inlay Removal Tool
Published
2021-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument
HWAImpactor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
HWAImpactorOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171004000Hintermann Series H2 Total Ankle SystemDt Medtech, LLC2017-11-07HSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B095319661PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
999-999-9999quality@dtmedtech.com
800-521-5002quality@dtmedtech.com

Regulatory Flags#

DUNS number
080101891
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B095319625Hintermann Series3196253196252021-01-16
B095319869Hintermann Series3198693198692021-01-15
B095319780Hintermann Series3197803197802021-01-11
B095119641Hintermann Series1196411196412018-10-04
B095309625Hintermann Series3096253096252018-10-03
B095319626Hintermann Series3196263196262018-10-03
B095319686Hintermann Series3196863196862018-10-16
B095319690Hintermann Series3196903196902018-10-16
B095319691Hintermann Series3196913196912018-10-16
B095319794Hintermann Series3197943197942018-10-16
B095319795Hintermann Series3197953197952018-10-16
B095319796Hintermann Series3197963197962018-10-16
B095322205Hintermann Series H23222053222052018-03-19
B095322206Hintermann Series H23222063222062018-03-19
B095322207Hintermann Series H23222073222072018-03-19
B095322209Hintermann Series H23222093222092018-03-19
B095322225Hintermann Series H23222253222252018-03-19
B095322515Hintermann Series H23225153225152018-03-20
B095322516Hintermann Series H23225163225162018-03-20
B095322519Hintermann Series H23225193225192018-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776411541MillenniumAvalign Technologies, Inc.HWA2026-08-07
B382SD923300150Surgical DirectSurgical Direct, Inc.FSM2026-08-07
B382SD923301040Surgical DirectSurgical Direct, Inc.FSM2026-08-07
00840606192002Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192019Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192026Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192033Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606192040Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194884Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194891Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194907Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194914Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194921Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194938Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194945Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194952Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194969Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194976Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194983Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606194990Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195003Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195010Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195027Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195034Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195041Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195058Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195065Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195539Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195669Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31
00840606195676Overwatch PCFSPINAL ELEMENTS, INC.FSM2026-07-31