FDA.report

VARIANT

Primary DI
B030SPO1530050
Brand
VARIANT
Company
CAMBER SPINE TECHNOLOGIES, LLC
Model
SPO-153-005
Device description
STORZ Adaptor
Published
2022-11-25
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
B030SPO1530050PrimaryHIBCC0

GMDN Terms

TermDefinition
Fibreoptic operating light systemA system of lights intended to be used in the operating room (OR) to illuminate the surgical site over a prolonged period for optimal visualization of small, low-contrast objects at varying depths or through small incisions. It operates through light provided by a light source, usually located outside of the surgical field, which is delivered through fibreoptic cables to the site of operation. The cables will be mounted, e.g., from the ceiling or attached to a suitable floor mount, or they may possibly connect directly to the surgeons head-worn head light.

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
true
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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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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