FDA.reportPublic FDA data

STOMA®

Primary DI
ESAM6045001
Brand
STOMA®
Company
Storz am Mark GmbH
Model
6045.00
Catalog number
6045.00
Device description
Wire bending pliers, Young, 14cm
Published
2020-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEXPLIER, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEXPlier, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESAM6045000Direct MarkingHIBCC0
ESAM6045001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wire holding/twisting forcepsA surgical instrument with specially designed sturdy blades used to grip, tighten and/or twist wires that are being applied to the patient during a surgical intervention. It typically has a scissors-like design with ring handles, is made of high-grade stainless steel and may be self-retaining. It is available in various sizes and the working end can have a variety of jaw designs, e.g., typically short and broad with carbide inserts, but some may be long with side protruding posts around which the loose end of the wire are secured to provide greater grip. The blades/handles are typically strong in profile. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49746592600sam@stoma.de

Regulatory Flags#

DUNS number
318268125
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ESAM14447011STOMA®14447.0114447.012026-05-26
ESAM14447021STOMA®14447.0214447.022026-05-26
ESAM14447031STOMA®14447.0314447.032026-05-26
ESAM14447041STOMA®14447.0414447.042026-05-26
ESAM3851141STOMA®3851.143851.142026-03-25
ESAM23040001STOMA®23040.0023040.002025-10-23
ESAM23049301STOMA®23049.3023049.302025-10-23
ESAM3387101STOMA®3387.103387.102020-08-27
ESAM12919001STOMA®12919.0012919.002020-08-27
ESAM12922001STOMA®12922.0012922.002020-08-27
ESAM12924001STOMA®12924.0012924.002020-08-27
ESAM12926001STOMA®12926.0012926.002020-08-27
ESAM12927001STOMA®12927.0012927.002020-08-27
ESAM12930001STOMA®12930.0012930.002020-08-27
ESAM12931001STOMA®12931.0012931.002020-08-27
ESAM23053141STOMA®23053.1423053.142023-06-19
ESAM2919101STOMA®2919.102919.102020-08-27
ESAM2922101STOMA®2922.102922.102020-08-27
ESAM2923101STOMA®2923.102923.102020-08-27
ESAM23051061STOMA® titanium bone screw23051.0623051.062015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611210074"PROMO KIT ICERAM-P MBT 0.022"""ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2024-04-16
07898506853069QuinelatoSchobell Industrial LtdaJEX2023-01-10
07898506814039QuinelatoSchobell Industrial LtdaJEX2022-12-16
07898506814244QuinelatoSchobell Industrial LtdaJEX2022-12-16
07898506841318QuinelatoSchobell Industrial LtdaJEX2022-12-16
07898506848669QuinelatoSchobell Industrial LtdaJEX2022-12-16
07898506850228QuinelatoSchobell Industrial LtdaJEX2022-12-16
07895742204273MorelliDental Morelli LtdaJEX2021-04-30
ESAM6005001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6011001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6015001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6026001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6028001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6030001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6034001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6047001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6071001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6073131STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6075001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6078001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6080001STOMA®Storz am Mark GmbHJEX2020-08-27
08033707076841LEONE SPALEONE SPAJEX2020-05-11
08033707096108LEONE SPALEONE SPAJEX2020-05-11
08033707082378LEONE SPALEONE SPAJEX2020-05-09
08033707082408LEONE SPALEONE SPAJEX2020-05-09
08033707082415LEONE SPALEONE SPAJEX2020-05-09
08033707084624LEONE SPALEONE SPAJEX2020-05-09
08033707084631LEONE SPALEONE SPAJEX2020-05-09
08033707084648LEONE SPALEONE SPAJEX2020-05-09
08033707084655LEONE SPALEONE SPAJEX2020-05-09