FDA.report

STOMA®

Primary DI
ESAM4623300
Brand
STOMA®
Company
Storz am Mark GmbH
Model
4623.30
Catalog number
4623.30
Device description
Scraper, Molt, fig.1, 3,0mm
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
EKECURETTE, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKECurette, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ESAM4623300Direct MarkingHIBCC0
ESAM4623301PrimaryHIBCC0

GMDN Terms

TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. 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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
D928105106HDHFDLC0CURETTE MOLT 2/4HD, HF D/E DLCW.H. Holden, Inc.EKE2026-01-06
D928105109JHF59DLC0CURETTE BONE #9J HF D/E SHORT HANDLE DLCW.H. Holden, Inc.EKE2026-01-06
D928105113CH0SINUS CURETTE D/E GOLEC CHW.H. Holden, Inc.EKE2025-02-06
D928105159CH0SINUS CURETTE K-N OBTUSE SMITH CH D/EW.H. Holden, Inc.EKE2024-12-18
D928105102HDFE0CURETTE MOLT #2HD EH-SM S/E **SPECIAL FLAT TIP**W.H. Holden, Inc.EKE2024-12-17
D928105104HO0CURETTE MOLT #4HD H/O HANDLEW.H. Holden, Inc.EKE2024-12-17
D92810510524RCH0CURETTE MOLT 2CH / 4HD, RIGHT, CH D/EW.H. Holden, Inc.EKE2024-12-17
D9281051066HFDLC0MOLT 4 DULL LEFT / RIGHT CURETTE, DLC, ACCORDING TO DR. CHANW.H. Holden, Inc.EKE2024-12-17
D928105109SHD0BONE CURETTE #9, STRAIGHT, 3.15mm /3.75MM, D/E SERRATED HDW.H. Holden, Inc.EKE2024-12-17
D92810511501HD0SINUS CURETTE B-2 MINI - CUSTOM INSTRUMENT HDW.H. Holden, Inc.EKE2024-12-17
D92810510524LCH0CURETTE MOLT 2CH / 4HD, LEFT, CH D/EW.H. Holden, Inc.EKE2024-12-03
D92810519916CH0CURETTE MOLT #4CH CH SPECIAL D/EW.H. Holden, Inc.EKE2024-12-03
D92810519916HF0CURETTE MOLT #4HD HF HANDLE SPECIAL D/EW.H. Holden, Inc.EKE2024-12-03
D928837102Z0BONE AUGMENTATION KIT ACC TO DR DANIEL CULLUMW.H. Holden, Inc.EKE2024-01-19
D928837151H0BONE TUNNELING KITW.H. Holden, Inc.EKE2024-01-19
D928837160H0LATERAL WINDOW SINUS CURETTE KIT ACC. TO DR. BART SILVERMANW.H. Holden, Inc.EKE2024-01-19
D9282007030ARNETT BONE CURETTEW.H. Holden, Inc.EKE2023-12-20
D9282007070ANTERIOR SINUS WALL CURETTEW.H. Holden, Inc.EKE2023-12-20
D928105102CH0CURETTE MOLT #2CH CH S/EW.H. Holden, Inc.EKE2023-10-10
D928105102CHE0CURETTE MOLT #2CH EH-SM S/EW.H. Holden, Inc.EKE2023-10-10
D928105102CHFE0CURETTE MOLT #2CH EH-SM S/E **SPECIAL FLAT TIP**W.H. Holden, Inc.EKE2023-10-10
D928105102CHHF0CURETTE MOLT #2CH HF S/EW.H. Holden, Inc.EKE2023-10-10
D928105102HD0CURETTE MOLT #2HD HD S/EW.H. Holden, Inc.EKE2023-10-10
D928105102HDE0CURETTE MOLT #2HD EH-SM S/EW.H. Holden, Inc.EKE2023-10-10
D928105102HDF0CURETTE MOLT #2HD HD S/E FLAT TIPW.H. Holden, Inc.EKE2023-10-10
D928105102HDH0CURETTE MOLT #2HD HF S/EW.H. Holden, Inc.EKE2023-10-10
D928105104CH0CURETTE MOLT #4CH CH S/EW.H. Holden, Inc.EKE2023-10-10
D928105104CHE0CURETTE MOLT #4CH EH-SM S/EW.H. Holden, Inc.EKE2023-10-10
D928105104CHLAKE0CURETTE MOLT #4CH CH SPECIAL D/EW.H. Holden, Inc.EKE2023-10-10
D928105104HD0CURETTE MOLT #4HD HD S/EW.H. Holden, Inc.EKE2023-10-10