FDA.report

Sequel Medical

Primary DI
00810071320415
Brand
Sequel Medical
Company
Sequel Medical Inc.
Model
IM12500010
Catalog number
IM12500010
Device description
M6 Bolt Connection 10mm – SST
Published
2021-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications

CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810071320415PrimaryGS10

GMDN Terms

TermDefinition
External orthopaedic fixation system, single-use, non-sterileAn assembly of non-sterile 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 intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
858-863-3826hdang@sequelmd.com

Regulatory Flags

DUNS number
109935591
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
true
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 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
00810071320750Sequel MedicalIM50000035IM500000352021-02-16
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

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