FDA.report

STOMA®

Primary DI
ESAM4033030
Brand
STOMA®
Company
Storz am Mark GmbH
Model
4033.03
Catalog number
4033.03
Device description
Mouth gags, Oringer, fig.3
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
KBNGAG, MOUTH

Product Code Classifications

CodeDeviceSpecialtyClass
KBNGag, MouthEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ESAM4033030Direct MarkingHIBCC0
ESAM4033031PrimaryHIBCC0

GMDN Terms

TermDefinition
Mouth gag, non-adjustableA mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention. It is designed to be inserted between the teeth to force the jaws apart and may be in the form of a wedge block, wedge screw, or sprung wedge. Depending on the design it may also be referred to as a jaw spreader, oral wood screw, or mouth prop. 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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