FDA.reportPublic FDA data

Salvin Kerrison Sinus Rongeur - 4 mm Bite

Primary DI
00841336103191
Brand
Salvin Kerrison Sinus Rongeur - 4 mm Bite
Company
Salvin Dental Specialties, Inc.
Model
KERRISON
Published
2023-08-10
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
EMEPunch, Biopsy, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMEPunch, Biopsy, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841336103191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841336103191008413361031918413361031910841336103191

GMDN Terms#

Term, Definition table
TermDefinition
Dental rongeurA strongly constructed dental instrument that is used in the removal of the sharp edges of the alveolar crest of the bone following tooth extraction. It has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws that bite (cut) through the bone tissue. It is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
113344790
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841336112032SalvinORAMEM-PLUS-15x202024-05-31
00841336112049SalvinORAMEM-PLUS-20x302024-05-30
00841336112056SalvinORAMEM-PLUS-30x402024-05-30
00841336111929SALVINOSS-BSALVINOSS-B-0.52024-05-27
00841336111936SALVINOSS-BSALVINOSS-B-1.02024-05-27
00841336111943SALVINOSS-BSALVINOSS-B-2.02024-05-27
00841336111950SALVINOSS-BSALVINOSS-B-4.02024-05-27
00841336111998SALVINOSS-BSALVINOSS-B-SYR-0.252024-05-27
00841336112001SALVINOSS-BSALVINOSS-B-SYR-0.502024-05-27
00841336112018SALVINOSS-BSALVINOSS-B-SYR-1.002024-05-27
00841336101760Salvin Stainless Steel UNC ProbePROBE-UNC2023-08-21
00841336103146Replacement Mallet Cap (Set of 2)MALLET-CAP2023-08-18
00841336103054#5 Front Surface Cone Socket Mirror - Box of 12MIRR-5-CS2023-08-16
00841336102675Flexible Stainless Steel Surgical Ruler - 6" (15.25cm)SURGRULER2023-08-11
00841336101128Salvin Adson Tissue Forcep-Curved-Serrated 4 3/4"ADSON-SERR-CURV2023-08-10
00841336101135Salvin Adson Titanium Curved Tissue Forceps 12cmADSON-TI-CURVED2023-08-10
00841336101142Salvin Bayonet Elevator Offset "In" - SmallBAYONET-ELEV-22023-08-10
00841336101159Salvin Debakey Atraumatic Tissue Forcep StraightDEBAKEY-STRAIGHT2023-08-10
00841336101166Salvin DEF 23 German Stainless Steel Extraction ForcepDEF 232023-08-10
00841336101173Salvin Serrated Elevator - 3mmDEL-SERR-32023-08-10

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Primary DI, Brand, Company table
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40649111233785Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
40649111234102Sklar InstrumentsSKLAR CORPORATIONEME2025-11-11
00841336113527Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEME2025-09-28
00841336128712Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEME2025-09-28
00841336113534Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEME2024-12-11
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