FDA.reportPublic FDA data

Osteotec Silicone Finger Implant Sizer Size 00

Primary DI
05060183090163
Brand
Osteotec Silicone Finger Implant Sizer Size 00
Company
OSTEOTEC LIMITED
Model
OSTF-S00
Catalog number
OSTF-S00
Device description
The Osteotec Silicone Finger Implant Sizer is a one-piece, blue flexible silicone elastomer device with the same dimensions as the Osteotec Silicone Finger Implant. The sizers are used initially as a guide to choosing the correct size of implant and then, once that choice is made, to insert into the prepared joint space to enable the surgeon to check fit and function e.g. range of motion
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
HWTTemplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060183090163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060183090163050601830901635060183090163

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. 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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