FDA.reportPublic FDA data

Sinus Curette

Primary DI
08800000949611
Brand
Sinus Curette
Company
Osstem Implant Co., Ltd.
Model
SNCRL
Published
2023-08-07
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

Product Codes#

Code, Name table
CodeName
EMKCurette, Surgical, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMKCurette, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800000949611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800000949611088000009496118800000949611

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
689051793
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800000987293Bone Screw, Bone TackBSCH14042026-03-09
08800000987309Bone Screw, Bone TackBSCH14062026-03-09
08800000987316Bone Screw, Bone TackBSCH14082026-03-09
08800000987323Bone Screw, Bone TackBSCH20082026-03-09
08800000987330Bone Screw, Bone TackBSCH20102026-03-09
08800000987347Bone Screw, Bone TackBSCH20122026-03-09
08800000987354Bone Screw, Bone TackBSCH20142026-03-09
08800000987361Bone Screw, Bone TackBSCH20162026-03-09
08800040644095Bone ScrewBSCH12032026-03-09
08800040644118Bone ScrewBSCH12042026-03-09
08800040644132Bone ScrewBSCH12052026-03-09
08800040654599Bone Screw, Bone TackOBT32026-03-09
08800040655848OssBuilder SystemSBS2008I2026-03-09
08800040655862OssBuilder SystemSBS2010I2026-03-09
08800040655886OssBuilder SystemSBS2011I2026-03-09
08800040655909OssBuilder SystemSBS2013I2026-03-09
08809892366858SS Abutment SystemSSCAP4814CTH2026-03-09
08809892366896SS Abutment SystemSSCAP4824CTH2026-03-09
08809892366957SS Abutment SystemSSCAP4826ENTH2026-03-09
08809892366964SS Abutment SystemSSCAP4826ETH2026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783007831Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMK2026-03-17
B382SD9162110970Surgical DirectSurgical Direct, Inc.EMK2026-03-02
B382SD916211098Surgical DirectSurgical Direct, Inc.EMK2026-03-02
B382SD9162111000Surgical DirectSurgical Direct, Inc.EMK2026-03-02
G1493800400TBS DentalACME ENTERPRISE.EMK2026-03-02
G1493800501TBS DentalACME ENTERPRISE.EMK2026-03-02
G1493806204TBS DentalACME ENTERPRISE.EMK2026-03-02
G149TBSBP03TBS DentalACME ENTERPRISE.EMK2026-03-02
B382SD915585140Surgical DirectSurgical Direct, Inc.EMK2026-02-25
B382SD48713950600Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD48800200Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD48800240Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD48810120Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD9155000200Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD9155000500Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915570020Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915570050Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915579000Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD915580070Surgical DirectSurgical Direct, Inc.EMK2026-02-04
B382SD9155911020Surgical DirectSurgical Direct, Inc.EMK2026-02-04
00841336106000Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106062Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106079Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106239Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106499Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106697Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336106918Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336108639Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336108653Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22
00841336109421Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMK2025-12-22