FDA.report

Diagon

Primary DI
B030MO1000090
Brand
Diagon
Company
CAMBER SPINE TECHNOLOGIES, LLC
Model
MO-100-009
Device description
Insertion Handle, Gripper Style
Published
2023-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B030MO1000090PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical instrument handle, torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(484) 427-7060quality@cambermedtech.com

Regulatory Flags

DUNS number
054205979
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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B030SCA151807100SPIRA-C IntegratedSCA-1518-07102025-08-04
B030SCA151807110SPIRA-C IntegratedSCA-1518-07112025-08-04
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B030SCZ1034000SPIRA-C IntegratedSCZ-103-4002025-08-04
B030SCZ103400060SPIRA-C IntegratedSCZ-103-400-062025-08-04
B030SCZ103400070SPIRA-C IntegratedSCZ-103-400-072025-08-04
B030SCZ103400080SPIRA-C IntegratedSCZ-103-400-082025-08-04
B030SCZ103400090SPIRA-C IntegratedSCZ-103-400-092025-08-04
B030SCZ103400100SPIRA-C IntegratedSCZ-103-400-102025-08-04
B030SCZ103400110SPIRA-C IntegratedSCZ-103-400-112025-08-04
B030SCZ103400120SPIRA-C IntegratedSCZ-103-400-122025-08-04
B030SCZ1034020SPIRA-C IntegratedSCZ-103-4022025-08-04
B030SCZ1034030SPIRA-C IntegratedSCZ-103-4032025-08-04
B030SCZ1035000SPIRA-C IntegratedSCZ-103-5002025-08-04
B030SCZ1170150SPIRA-C IntegratedSCZ-117-0152025-08-04
B030SCZ1170160SPIRA-C IntegratedSCZ-117-0162025-08-04

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