FDA.report

STOMA®

Primary DI
ESAM3455170
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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EJGFORCEPS, RUBBER DAM CLAMP

Product Code Classifications

CodeDeviceSpecialtyClass
EJGForceps, Rubber Dam ClampDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ESAM3455170Direct MarkingHIBCC0
ESAM3455171PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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

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ESAM23053120STOMA®23053.1223053.122025-04-30
ESAM23080000STOMA®23080.0023080.002025-04-30
ESAM23080131STOMA®23080.1323080.132025-04-30
ESAM23080160STOMA®23080.1623080.162025-04-30
ESAM3840130STOMA®3840.133840.132025-04-30
ESAM3841130STOMA®3841.133841.132025-04-30
ESAM4028010STOMA®4028.014028.012025-04-30
ESAM6550400STOMA®6550.406550.402025-04-30
ESAM6551100STOMA®6551.106551.102025-04-30
ESAM14140470STOMA®14140.4714140.472025-04-23

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