FDA.reportPublic FDA data

STOMA®

Primary DI
ESAM6005000
Brand
STOMA®
Company
Storz am Mark GmbH
Model
6005.00
Catalog number
6005.00
Device description
Flat pliers, Langenbeck, 15cm
Published
2020-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
ESAM6005000Direct MarkingHIBCC0
ESAM6005001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical flat-nosed pliersA heavy-duty, surgical instrument with specially designed sturdy handles and gripping jaws (typically parallel) used to grip and hold an object during a surgical intervention. It has a scissors-like design with curved handles and is made of high-grade stainless steel. It is available in various sizes and the jaws (typically broad with serrations) at the working end are activated through a single pivot or a double ratio-lever exchange pivot to provide greater gripping force. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
07898488905107WEINGART PLIER W/OUT WIDIAORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07898488907217TUBE CONVERSION PLIER – 4003ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07898488909945ELASTIC LIGATURE APPLICATOR/REMOVERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908470705735PLIER ANGLE W/ WIDIA AND CUTTING (139)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908470705803TORQUE PLIER SHORT (442)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908611200129PLIER FOR LONG TORQUE (442)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908611204325ANGULAR BRACKET REMOVAL PLIERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
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
ESAM6045001STOMA®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