SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USE

Primary DI
13760087123712
Brand
SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USE
Company
FCI S A S FCI 20 22
Model
S6.3060
Device description
A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.
Published
2021-05-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HPZImplant, Eye Sphere

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPZImplant, Eye SphereOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13760087123712PackageGS11Not in Commercial Distribution
03760087123715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1376008712371213760087123712
03760087123715037600871237153760087123715

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, single-useA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
763408366
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
13700773729651STOPLOSS® JONES TUBE 3,5 X 9 MM S1.73092026-04-20
13700773729668STOPLOSS® JONES TUBE 3,5 X 10 MM S1.73102026-04-20
13700773729675STOPLOSS® JONES TUBE 3,5 X 11 MM S1.73112026-04-20
13700773729682STOPLOSS® JONES TUBE 3,5 X 12 MM S1.73122026-04-20
13700773729699STOPLOSS® JONES TUBE 3,5 X 13 MM S1.73132026-04-20
13700773730817STOPLOSS® JONES TUBE INTRODUCER SET S1.75002026-04-20
13700773731920STOPLOSS® JONES TUBE 3,5 X 14 MM S1.73142026-04-20
13700773731937STOPLOSS® JONES TUBE 3,5 X 15 MM S1.73152026-04-20
13700773731968STOPLOSS® JONES TUBE 3,5 X 16 MM S1.73162026-04-20
13700773731975STOPLOSS® JONES TUBE 3,5 X 17 MM S1.73172026-04-20
13700773731982STOPLOSS® JONES TUBE 3,5 X 18 MM S1.73182026-04-20
13700773731999STOPLOSS® JONES TUBE 3,5 X 19 MM S1.73192026-04-20
13700773732002STOPLOSS® JONES TUBE 3,5 X 20 MM S1.73202026-04-20
13700773732019STOPLOSS® JONES TUBE 3,5 X 21 MM S1.73212026-04-20
13700773732026STOPLOSS® JONES TUBE 3,5 X 22 MM S1.73222026-04-20
13700773732033STOPLOSS® JONES TUBE 4 X 9 MM S1.74092026-04-20
13700773732040STOPLOSS® JONES TUBE 4 X 10 MM S1.74102026-04-20
13700773732057STOPLOSS® JONES TUBE 4 X 11 MM S1.74112026-04-20
13700773732064STOPLOSS® JONES TUBE 4 X 12 MM S1.74122026-04-20
13700773732071STOPLOSS® JONES TUBE 4 X 13 MM S1.74132026-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
13700773728111SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USEFCI S A S FCI 20 22HPZ2026-02-17
13700773724397EZYPOR® Ø 18 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773724403EZYPOR® Ø 20 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773724410EZYPOR® Ø 22 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773728081EZYPOR® Ø 16 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773728852EZYPOR® Ø 12 mm FCI S A S FCI 20 22HPZ2024-06-21
13700773728890EZYPOR® Ø 14 mm FCI S A S FCI 20 22HPZ2024-06-21
B09114150010mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114151012mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114152014mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114153016mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114154018mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114155020mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
B09114156022mm Eye Sphere (non-sterile)Gulden Ophthalmics Inc.HPZ2023-07-19
03760087123715SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USEFCI S A S FCI 20 22HPZ2021-05-30
03760087122435Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122442Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122459Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122466Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122473Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122480Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122510Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122527Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122916Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122923Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122930Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122954Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122961Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087122985Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06
03760087123067Orbital sphere implantFCI S A S FCI 20 22HPZ2020-03-06