FDA.reportPublic FDA data

STOMA®

Primary DI
ESAM3455171
Brand
STOMA®
Company
Storz am Mark GmbH
Model
3455.17
Catalog number
3455.17
Device description
Rubber dam clamp forceps, Brewer,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
EJGFORCEPS, RUBBER DAM CLAMP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJGForceps, Rubber Dam ClampDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESAM3455170Direct MarkingHIBCC0
ESAM3455171PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam clamp forcepsA hand-held dental instrument used for the insertion and removal of rubber dam clamps. It is typically designed with permanently joined handles pivoted scissor-like, and has small projections at the working end that fit into corresponding holes in the rubber dam clamp. It will typically have a sliding lock mechanism that locks the handles in position while the operator moves the rubber dam clamp around the tooth. 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
ESAM1380200003041STOMA®138-020000-304138-020000-3042026-07-30
ESAM1380210003041STOMA®138-021000-304138-021000-3042026-07-30
ESAM1387030003041STOMA®138-703000-304138-703000-3042026-07-30
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

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Primary DI, Brand, Company table
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G8791032720DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
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G8791032760DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEJG2026-08-22
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G149TBSB2150TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2160TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2170TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2180TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2190TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2200TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2210TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2220TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2230TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2240TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2250TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2260TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2270TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2280TBS BASICSACME ENTERPRISE.EJG2026-05-16
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