FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660152413
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Oral surgery exodontia rongeur
Catalog number
75-850
Device description
Oral surgery exodontia rongeur, 5 3/4'', #5S, spring handle
Published
2021-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMHFORCEPS, RONGEUR, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMHForceps, Rongeur, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660152413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660152413001906601524131906601524130190660152413

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

Contacts#

Phone, Email table
PhoneEmail
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags#

DUNS number
015272206
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190660100360Ambler SurgicalFiberoptic light cable40-8002021-01-04
00190660100377Ambler SurgicalFiberoptic light cable40-5002021-01-04
00190660100384Ambler SurgicalFiberoptic light cable40-8102021-01-04
00190660100391Ambler SurgicalFiberoptic light cable40-5052021-01-04
00190660100407Ambler SurgicalFiberoptic light cable40-8202021-01-04
00190660100414Ambler SurgicalFiberoptic light cable40-8302021-01-04
00190660100421Ambler SurgicalFiberoptic light cable40-5102021-01-04
00190660100438Ambler SurgicalFiberoptic light cable40-5152021-01-04
00190660100445Ambler SurgicalFiberoptic light cable40-5202021-01-04
00190660100452Ambler SurgicalFiberoptic light cable40-5252021-01-04
00190660100469Ambler SurgicalFiberoptic light cable40-5302021-01-04
00190660100476Ambler SurgicalFiberoptic light cable40-5352021-01-04
00190660100483Ambler SurgicalFiberoptic light cable40-8402021-01-04
00190660100490Ambler SurgicalFiberoptic light cable40-8502021-01-04
00190660100506Ambler SurgicalFiberoptic light cable40-8602021-01-04
00190660100513Ambler SurgicalFiberoptic light cable40-5402021-01-04
00190660100520Ambler SurgicalFiberoptic light cable40-6002021-01-04
00190660100537Ambler SurgicalFiberoptic light cable40-6102021-01-04
00190660100544Ambler SurgicalFiberoptic light cable40-1002021-01-04
00190660100551Ambler SurgicalFiberoptic light cable40-6202021-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB7330TBS BASICSACME ENTERPRISE.EMH2026-05-21
G149TBSB7340TBS BASICSACME ENTERPRISE.EMH2026-05-21
G149TBSB7350TBS BASICSACME ENTERPRISE.EMH2026-05-21
G149TBSB7360TBS BASICSACME ENTERPRISE.EMH2026-05-21
G149NP380640NPSACME ENTERPRISE.EMH2026-05-01
B7688386020Buxton BioMedicalBuxton Biomedical IncEMH2026-04-23
B7688441030Buxton BioMedicalBuxton Biomedical IncEMH2026-04-23
B76884751040Buxton BioMedicalBuxton Biomedical IncEMH2026-04-23
B76884754320Buxton BioMedicalBuxton Biomedical IncEMH2026-04-23
B7688532061030Buxton BioMedicalBuxton Biomedical IncEMH2026-04-23
B7688532351120Buxton BioMedicalBuxton Biomedical IncEMH2026-04-23
B7688532351130Buxton BioMedicalBuxton Biomedical IncEMH2026-04-23
B7688650540Buxton BioMedicalBuxton Biomedical IncEMH2026-04-23
00810158219229PRINCETONPrinceton Medical Group, Inc.EMH2026-03-12
00810158219076PRINCETONPrinceton Medical Group, Inc.EMH2026-03-11
00810158219083PRINCETONPrinceton Medical Group, Inc.EMH2026-03-11
00810158219120PRINCETONPrinceton Medical Group, Inc.EMH2026-03-11
04059453090195Hermann Medizintechnik GmbHHermann Medizintechnik GmbHEMH2026-01-29
D9281009301850RONGEUR DOUBLE ACTION RUSKIN CURVED 18CM, 5MMW.H. Holden, Inc.EMH2026-01-06
D9281009302390RONGEUR DOUBLE ACTION RUSKIN CURVED 23CM, 6MMW.H. Holden, Inc.EMH2026-01-06
B7688441020Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
B7688457751630Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
B76885362280Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
B76885362360Buxton BioMedicalBuxton Biomedical IncEMH2025-12-31
08809596474019Kerrison Rotating Rongeur ShaftHankil Tech Medical Co., Ltd.EMH2025-12-16
08809596474071Endo Scope Kerrision Rotating Rongeur ShaftHankil Tech Medical Co., Ltd.EMH2025-12-16
08809596474095Endo Scope Kerrision Rotating Rongeur ShaftHankil Tech Medical Co., Ltd.EMH2025-12-16
08809596474996Kerrison Rotating Rongeur HandleHankil Tech Medical Co., Ltd.EMH2025-12-16
B356ED107160American MedicalsAmerican MedicalsEMH2025-12-03
B7688457751030Buxton BioMedicalBuxton Biomedical IncEMH2025-11-21