FDA.reportPublic FDA data

Osteotec CBG Ejector L

Primary DI
05060183095670
Brand
Osteotec CBG Ejector L
Company
OSTEOTEC LIMITED
Model
OST-CBG-19
Catalog number
OST-CBG-19
Device description
The graft extractors are used to remove the ‘plug’ of bone from the end of the tube saw after it has been removed.
Published
2022-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
05060183095670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060183095670050601830956705060183095670

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic counter-torque/rod-pushing instrumentA hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
348489386
Device count
1
Premarket exempt
true
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
05060183095793Osteotec SFI InstrumentsOSTF-InsOSTF-Ins2025-11-26
05060183095809Osteotec SFI SizerOSTF-SizerOSTF-Sizer2025-11-26
05060183090002Osteotec Silicone Finger Implant - Size 00OSTF-00OSTF-002022-02-04
05060183090019Osteotec Silicone Finger Implant - Size 0OSTF-0OSTF-02022-02-04
05060183090026Osteotec Silicone Finger Implant - Size 1OSTF-1OSTF-12022-02-04
05060183090033Osteotec Silicone Finger Implant - Size 2OSTF-2OSTF-22022-02-04
05060183090040Osteotec Silicone Finger Implant - Size 3OSTF-3OSTF-32022-02-04
05060183090057Osteotec Silicone Finger Implant - Size 4OSTF-4OSTF-42022-02-04
05060183090064Osteotec Silicone Finger Implant - Size 5OSTF-5OSTF-52022-02-04
05060183090071Osteotec Silicone Finger Implant - Size 6OSTF-6OSTF-62022-02-04
05060183090088Osteotec Silicone Finger Implant - Size 7OSTF-7OSTF-72022-02-04
05060183090095Osteotec Silicone Finger Implant - Size 8OSTF-8OSTF-82022-02-04
05060183090101Osteotec Silicone Finger Implant - Size 9OSTF-9OSTF-92022-02-04
05060183095595Osteotec CBG Tube Saw S - size 1OST-CBG-01OST-CBG-012022-02-04
05060183095601Osteotec CBG Tube Saw S - size 2OST-CBG-02OST-CBG-022022-02-04
05060183095618Osteotec CBG Tube Saw S - size 3OST-CBG-03OST-CBG-032022-02-04
05060183095625Osteotec CBG Tube Saw S - size 4OST-CBG-04OST-CBG-042022-02-04
05060183095632Osteotec CBG Tube Saw L - size 5OST-CBG-05OST-CBG-052022-02-04
05060183095649Osteotec CBG Tube Saw L - size 6OST-CBG-06OST-CBG-062022-02-04
05060183095656Osteotec CBG Tube Saw L - size 7OST-CBG-07OST-CBG-072022-02-04

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