FDA.report

STOMA®

Primary DI
ESAM2730000
Brand
STOMA®
Company
Storz am Mark GmbH
Model
2730.00
Catalog number
2730.00
Device description
Scaler CI2-3, Ø 8mm
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
EMNSCALER, PERIODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ESAM2730000Direct MarkingHIBCC0
ESAM2730001PrimaryHIBCC0

GMDN Terms

TermDefinition
Manual dental scaler, reusableA hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. 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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ESAM23080131STOMA®23080.1323080.132025-04-30
ESAM23080160STOMA®23080.1623080.162025-04-30
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ESAM6551100STOMA®6551.106551.102025-04-30
ESAM14140470STOMA®14140.4714140.472025-04-23

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