FDA.report

STOMA®

Primary DI
ESAM3710000
Brand
STOMA®
Company
Storz am Mark GmbH
Model
3710.00
Catalog number
3710.00
Device description
Root canal forceps, 13cm
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
DZNINSTRUMENTS, DENTAL HAND

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ESAM3710000Direct MarkingHIBCC0
ESAM3710001PrimaryHIBCC0

GMDN Terms

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
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
ESAM1000STOMA®1.00 1.00 2025-04-30
ESAM13309100STOMA®13309.1013309.102025-04-30
ESAM14060470STOMA®14060.4714060.472025-04-30
ESAM14061470STOMA®14061.4714061.472025-04-30
ESAM14065470STOMA®14065.4714065.472025-04-30
ESAM14089470STOMA®14089.4714089.472025-04-30
ESAM14094470STOMA®14094.4714094.472025-04-30
ESAM14446250STOMA®14446.2514446.252025-04-30
ESAM14621760STOMA®14621.7614621.762025-04-30
ESAM14762480STOMA®14762.4814762.482025-04-30
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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06438311708676LMDentalLM-DentalDZN2026-03-23
06438311708683LMDentalLM-DentalDZN2026-03-23
06438311708690LMDentalLM-DentalDZN2026-03-23
06438311708706LMDentalLM-DentalDZN2026-03-23
06438311708713LMDentalLM-DentalDZN2026-03-23
06438311708720LMDentalLM-DentalDZN2026-03-23
06438311708737LMDentalLM-DentalDZN2026-03-23
06438311708744LMDentalLM-DentalDZN2026-03-23
06438311708751LMDentalLM-DentalDZN2026-03-23
06438311708768LMDentalLM-DentalDZN2026-03-23
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