FDA.reportPublic FDA data

Long Rongeur w/ Ratchet Handle

Primary DI
00847538015713
Brand
Long Rongeur w/ Ratchet Handle
Company
SYMMETRY MEDICAL INC.
Model
74-479-000
Catalog number
2709-01-016
Device description
Long Rongeur w/ Ratchet Handle
Published
2022-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00847538015713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847538015713008475380157138475380157130847538015713

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, alligator, reusableA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079881212
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847538007787Component Impactor10-016-400-15002011-03-0372022-05-17
00847538005479Patella Caliper802-01-1122025-12-10
00847538007930Bone Hook - Small10-257-000803-61-0252025-10-20
00847538008654HP Extraction Standard Removal Case87-10082011-03-0482023-11-28
00847538015256Flexible Osteotome System with Radel Case30-005-0002709-04-000; 30-005-000-15002023-07-17
00847538019179Femoral Tray30-037-4002709-01-000; 30-037-400-15002023-07-17
00817766026423GLOBAL UNITE™ Short Stem Instrumentation2236002112021-09-01
00847538010558Tuning Fork12-070-0002011-03-0302022-05-17
00847538010565MBT Tray/Sleeve Separator12-071-4002011-03-0532022-05-17
00847538010572Sleeve Removal Tool12-072-0002011-03-0312022-05-17
00847538005431Extraction Screw, 8 MM12-010-000-15002011-03-0422022-05-13
00847538010527Head Extractor12-063-0002500-00-7792022-05-13
00847538010534Forked Stem Extractor Wide12-065-0002500-00-7812022-05-13
00847538010541Forked Stem Extractor Narrow12-067-0002500-00-7802022-05-13
00847538015751Adapter Slaphammer to Locking Pliers12-053-000-15002011-03-0462022-05-13
00847538015768Stem Trial Remover Slaphammer adapter12-054-000-15002011-03-0472022-05-13
00847538015775Tibial Component Extractor74-591-000-15002011-03-0452022-05-13
00847538007916Head Removal Fork10-246-4002500-00-7762022-05-12
00847538001471T-Bar Stem Extractor10-062-0002709-05-003;00-9986-040-122022-05-11
00847538010473Driver Shaft w/Slaphammer w/Hudson Connector12-048-0002709-05-0012022-05-11

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