FDA.reportPublic FDA data

Panama™

Primary DI
B1830870000100
Brand
Panama™
Company
FLOSPINE LLC
Model
Panama™
Catalog number
08-70000-010
Device description
AO Pull-Connect Handle
Published
2021-10-20
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1830870000100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-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, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5617053080info@flospine.com

Regulatory Flags#

DUNS number
042993143
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B1830171000120Canaveral®Canaveral®01-7100-0122025-04-04
B1830172000360Canaveral®Canaveral®01-7200-0362025-04-04
B1830172000370Canaveral®Canaveral®01-7200-0372025-04-04
B183FSBMHN1104X0Bone Marrow Harvest NeedleFS-BMHN1104XFS-BMHN1104X2025-04-04
B183FSDBANJ0806TL0Bone Acess NeedleFS-DBANJ0806TLFS-DBANJ0806TL2025-04-04
B183FSDBANJ1106TL0Bone Acess NeedleFS-DBANJ1106TLFS-DBANJ1106TL2025-04-04
B1830112000010Canaveral®Canaveral®01-1200-0012016-06-30
B1830112450500Canaveral®Canaveral®01-1245-0502025-03-28
B1830111450500Canaveral®Canaveral®01-1145-0502025-03-26
B1830113450500Canaveral®Canaveral®01-1345-0502025-03-24
B1830113550300Canaveral®Canaveral®01-1355-0302025-03-24
B1830113650250Canaveral®Canaveral®01-1365-0252025-03-24
B1830112150300Canaveral®Canaveral®01-1215-0302016-06-30
B1830112150350Canaveral®Canaveral®01-1215-0352016-06-30
B1830112150600Canaveral®Canaveral®01-1215-0602016-06-30
B1830112151000Canaveral®Canaveral®01-1215-1002016-06-30
B1830112151100Canaveral®Canaveral®01-1215-1102016-06-30
B1830112450350Canaveral®Canaveral®01-1245-0352016-06-30
B1830112450400Canaveral®Canaveral®01-1245-0402016-06-30
B1830112450450Canaveral®Canaveral®01-1245-0452016-06-30

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