FDA.reportPublic FDA data

Osteotec Silicone Finger - All In One Silicone Finger Tray, empty

Primary DI
05060183095571
Brand
Osteotec Silicone Finger - All In One Silicone Finger Tray, empty
Company
OSTEOTEC LIMITED
Model
OSTF-INS8
Catalog number
OSTF-INS8
Device description
Instrument Tray for the Osteotec Silicone Finger Instruments
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
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060183095571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060183095571050601830955715060183095571

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. 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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