FDA.reportPublic FDA data

Sequel Medical

Primary DI
00810071320750
Brand
Sequel Medical
Company
Sequel Medical Inc.
Model
IM50000035
Catalog number
IM50000035
Device description
Half Pins 5mm x 35mm
Published
2021-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDWPin, Fixation, Threaded
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDWPin, Fixation, ThreadedOrthopedic2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810071320750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071320750008100713207508100713207500810071320750

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-useAn assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
858-863-3826hdang@sequelmd.com

Regulatory Flags#

DUNS number
109935591
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810071321894Sequel Medical 201-1001S201-1001S2025-09-18
00810071321900Sequel Medical 201-1002M201-1002M2025-09-18
00810071321917Sequel Medical 201-1003L201-1003L2025-09-18
00810071320729Sequel MedicalIM50000020IM500000202021-02-16
00810071320736Sequel MedicalIM50000025IM500000252021-02-16
00810071320743Sequel MedicalIM50000030IM500000302021-02-16
00810071320767Sequel MedicalIM50000040IM500000402021-02-16
00810071320774Sequel MedicalIM60000020IM600000202021-02-16
00810071320781Sequel MedicalIM60000025IM600000252021-02-16
00810071320798Sequel MedicalIM60000030IM600000302021-02-16
00810071320804Sequel MedicalIM60000035IM600000352021-02-16
00810071320811Sequel MedicalIM60000040IM600000402021-02-16
00810071321054Sequel MedicalIM12220200AIM12220200A2021-08-16
00810071321061Sequel MedicalIM12220220AIM12220220A2021-08-16
00810071321078Sequel MedicalIM12220240AIM12220240A2021-08-16
00810071321146Sequel Medical200-0002200-00022021-08-16
00810071321153Sequel Medical220-0002220-00022021-08-16
00810071321160Sequel Medical240-0002240-00022021-08-16
00810071321504Sequel MedicalIM1700015IM17000152021-08-16
00810071321511Sequel MedicalIM1700017IM17000172021-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08032909626380ST.A.R. 90 F4CITIEFFE SRLKTT2026-03-17
08032909624256ST.A.R. 90 F4CITIEFFE SRLJDW2024-09-11
08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624270ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624317ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624355ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624362ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909627639DOLPHIXCITIEFFE SRLKTT2020-01-10
08051739531237DOLPHIXCITIEFFE SRLJDW2019-05-18
08051739531244DOLPHIXCITIEFFE SRLKTT2019-05-18
08051739531251DOLPHIXCITIEFFE SRLJDW2019-05-18
08051739535334ST.A.R. 90 F4CITIEFFE SRLJDW2019-04-04
08051739531800DOLPHIXCITIEFFE SRLJDW2019-03-21
08051739531725DOLPHIXCITIEFFE SRLJDW2019-01-09
08051739531725DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531732DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531732DOLPHIXCITIEFFE SRLJDW2019-01-09
08051739531749DOLPHIXCITIEFFE SRLJDW2019-01-09
08051739531749DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531756DOLPHIXCITIEFFE SRLJDW2018-12-15
08051739531756DOLPHIXCITIEFFE SRLKTT2018-12-15
08051739531763DOLPHIXCITIEFFE SRLJDW2018-12-15
08051739531763DOLPHIXCITIEFFE SRLKTT2018-12-15
08051739531770DOLPHIXCITIEFFE SRLKTT2018-12-15
08051739531770DOLPHIXCITIEFFE SRLJDW2018-12-15
08051739531787DOLPHIXCITIEFFE SRLKTT2018-12-15
08051739531787DOLPHIXCITIEFFE SRLJDW2018-12-15
08051739531268DOLPHIXCITIEFFE SRLJDW2018-10-17
08051739531268DOLPHIXCITIEFFE SRLKTT2018-10-17
08051739531275DOLPHIXCITIEFFE SRLJDW2018-10-17