FDA.reportPublic FDA data

Osteotec Silicone Finger - Proximal Rasp Size 0

Primary DI
05060183090576
Brand
Osteotec Silicone Finger - Proximal Rasp Size 0
Company
OSTEOTEC LIMITED
Model
OSTF-0P
Catalog number
OSTF-0P
Device description
The 11 distal (blue handle) and 11 proximal (whithe handle) rasps are device specific instruments used to create bone cavities for the implantation of the Osteotec Silicone Finger Implant. Each rasp is dedicated to a particular size of implant and is based on the design of the proximal or distal stem.
Published
2022-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTQBroach

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTQBroachOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060183090576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060183090576050601830905765060183090576

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manualA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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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