FDA.reportPublic FDA data

STOMA®

Primary DI
ESAM3245171
Brand
STOMA®
Company
Storz am Mark GmbH
Model
3245.17
Catalog number
3245.17
Device description
Bone cutting forceps, Cleveland,17cm
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
EMHFORCEPS, RONGEUR, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMHForceps, Rongeur, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESAM3245170Direct MarkingHIBCC0
ESAM3245171PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental rongeurA strongly constructed dental instrument that is used in the removal of the sharp edges of the alveolar crest of the bone following tooth extraction. It has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws that bite (cut) through the bone tissue. It is made of high-grade stainless steel. 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

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G149TBSB7360TBS BASICSACME ENTERPRISE.EMH2026-05-21
G149NP380640NPSACME ENTERPRISE.EMH2026-05-01
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00810158219120PRINCETONPrinceton Medical Group, Inc.EMH2026-03-11
04059453090195Hermann Medizintechnik GmbHHermann Medizintechnik GmbHEMH2026-01-29
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08809596474095Endo Scope Kerrision Rotating Rongeur ShaftHankil Tech Medical Co., Ltd.EMH2025-12-16
08809596474996Kerrison Rotating Rongeur HandleHankil Tech Medical Co., Ltd.EMH2025-12-16
B356ED107160American MedicalsAmerican MedicalsEMH2025-12-03
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