FDA.reportPublic FDA data

Hintermann Series

Primary DI
00841731135452
Brand
Hintermann Series
Company
VILEX LLC
Model
HT-39993
Device description
Hintermann Series Horseshoe Pin Caddy
Published
2025-09-17
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
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240475000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240475000Hintermann Series H2 Total Ankle SystemVilex, LLC2024-12-02HSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731135452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731135452008417311354528417311354520841731135452

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental 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 or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place
Special Storage Condition, Specify00Store in a dry place.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)521-5002info@vilex.com

Regulatory Flags#

DUNS number
117502293
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841731135483TITANEX H4102026-05-15
00841731135568TITANEX K150-16SC2026-05-15
00841731137319TITANEX ART-KW2-1012026-05-15
00841731137906TITANEXK150-09S2026-05-15
00841731137913TITANEX TH-DRILL-202026-05-15
00841731137920TITANEX TH-DRILL-252026-05-15
00841731137937TITANEXTH-DEPTHTH-DEPTH2026-05-15
00841731137951TITANEX TH-DT72026-05-15
00841731137968TITANEX TH-DT82026-05-15
00841731138095TITANEX ART-KW2-1902026-05-15
00841731138101TITANEX ART-KWS-222026-05-15
00841731138118TITANEX ART-DTH-652026-05-15
00841731138125TITANEX ART-STP-492026-05-15
00841731138132TITANEX ART-DBC-492026-05-15
00841731138149TITANEX ART-RT-T252026-05-15
00841731138156TITANEX ART-VZO-152026-05-15
00841731140777TITANEX AZ-D130-262026-05-15
00841731140784TITANEX AZ-DT10-CR2026-05-15
00841731141910TITANEX AZ-D150-332026-05-15
00841731141927TITANEX AZ-DT15-CR2026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630008405793APTUSMedartis AGFSM2026-07-16
07630008405809APTUSMedartis AGFSM2026-07-16
07630008405878APTUSMedartis AGFSM2026-07-16
07630008405892APTUSMedartis AGFSM2026-07-16
07630008406226APTUSMedartis AGFSM2026-07-16
07630008406233APTUSMedartis AGFSM2026-07-16
07630008406240APTUSMedartis AGFSM2026-07-16
07630008406257APTUSMedartis AGFSM2026-07-16
07630008406264APTUSMedartis AGFSM2026-07-16
07630008406271APTUSMedartis AGFSM2026-07-16
07630008406288APTUSMedartis AGFSM2026-07-16
07630008406295APTUSMedartis AGFSM2026-07-16
07630008406301APTUSMedartis AGFSM2026-07-16
07630008406318APTUSMedartis AGFSM2026-07-16
07630008406325APTUSMedartis AGFSM2026-07-16
07630008406332APTUSMedartis AGFSM2026-07-16
07630008428327APTUSMedartis AGFSM2026-07-16
07630008428334APTUSMedartis AGFSM2026-07-16
07630008453206APTUSMedartis AGFSM2026-07-16
07630008488284APTUSMedartis AGFSM2026-07-16
07630008488314APTUSMedartis AGFSM2026-07-16
07630008488406APTUSMedartis AGFSM2026-07-16
07630037833475APTUSMedartis AGFSM2026-07-16
07630037833482APTUSMedartis AGFSM2026-07-16
07630037846437APTUSMedartis AGFSM2026-07-16
07630037846444APTUSMedartis AGFSM2026-07-16
07630037846697APTUSMedartis AGFSM2026-07-16
07630037846802APTUSMedartis AGFSM2026-07-16
07630037847229APTUSMedartis AGFSM2026-07-16
07630037847236APTUSMedartis AGFSM2026-07-16