FDA.reportPublic FDA data

n.a.

Primary DI
04048551080917
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
227525
Device description
FISCH Cutting Block
Published
2016-09-23
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
ETAREPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETAReplacement, Ossicular Prosthesis, TotalEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551080917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551080917040485510809174048551080917

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Hydrogen Peroxide"", ""Ethylene Oxide"", ""Peracetic Acid""]"
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide;Peracetic Acid

Regulatory Flags#

DUNS number
315731430
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048551001141n.a.495NCS2016-09-23
04048551004401n.a.495TIP2016-09-23
04048551004463n.a.50200FFL2018-08-21
04048551028568n.a.495ADM2016-09-23
04048551049549n.a.10970AE2018-08-17
04048551049563n.a.10970BE2018-08-17
04048551052495n.a.12016EM2016-09-23
04048551052525n.a.12016FM2016-09-23
04048551052990n.a.12061A2016-09-23
04048551053003n.a.12061AU2016-09-23
04048551053010n.a.12061AV2016-09-23
04048551053027n.a.12061AW2016-09-23
04048551053034n.a.12061AX2016-09-23
04048551053041n.a.12061B2016-09-23
04048551053065n.a.12061C2016-09-23
04048551053072n.a.12061F2016-09-23
04048551053089n.a.12061G2016-09-23
04048551053096n.a.12061H2016-09-23
04048551053102n.a.12061K2016-09-23
04048551082027n.a.233250B2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00844505014663OFFSET TITANIUM WILDCAT ALTOGrace Medical, Inc.ETA2025-07-17
00763000913489N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913496BojrabMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913502Causse/PolycelMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913519Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913526Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913533Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913540Causse/Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913557Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913564Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913571Causse/VincentMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913595Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913601Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913625N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913632N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913649N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913656N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913663SilversteinMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913717Sheehy/PolycelMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913724Sheehy/PolycelMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913731N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913762N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000033385HA/C Polycel® Brackmann TotalMEDTRONIC XOMED, INC.ETA2024-05-12
00763000034832Sheehy HA/C Polycel® P.O.P.MEDTRONIC XOMED, INC.ETA2024-05-12
00763000034849Sheehy HA/C Polycel® T.O.P.MEDTRONIC XOMED, INC.ETA2024-05-12
00763000036591Big Easy® PistonMEDTRONIC XOMED, INC.ETA2024-05-12
00763000036607Big Easy® PistonMEDTRONIC XOMED, INC.ETA2024-05-12
00763000036614Big Easy® PistonMEDTRONIC XOMED, INC.ETA2024-05-12
00763000036621Big Easy® PistonMEDTRONIC XOMED, INC.ETA2024-05-12
00763000036638Big Easy® PistonMEDTRONIC XOMED, INC.ETA2024-05-12