FDA.report

EXPLORER PROBE

Primary DI
B974DEP500000
Brand
EXPLORER PROBE
Company
DR.FRIGZ INTERNATIONAL(PVT)LTD,
Model
EXPLORER PROBE
Catalog number
DEP5000
Device description
EXPLORER PROBE WITH MARKING, 158 MM
Published
2022-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EKBExplorer, Operative

Product Code Classifications

CodeDeviceSpecialtyClass
EKBExplorer, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B974DEP500000PrimaryHIBCC0

GMDN Terms

TermDefinition
Ophthalmic soft-tissue surgical forceps probe-tip, single-useA sterile distal component of a probe-like ophthalmic soft-tissue surgical forceps assembly designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It is a probe-/cannula-like shaft with small grasping blades that protrude from the end of the shaft, and is intended to be attached to an appropriate ophthalmic surgical instrument handle (not included). This is a single-use device.

Device Sizes

TypeValueUnit
Length158Millimeter

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
645680125
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
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 DIBrandModelCatalogPublished
B974111310SCISSORSTENOTOMY SCISSORS111312022-11-22
B974111400Single Use ScissorEPISIOTOMY SCISSORS111402022-11-22
B974122000FORCEPSPEAN FORCEPS122002022-11-22
B974132420FORCEPSLORNA TOWEL FORCEPS132422022-11-22
B974132430FORCEPSLORNA TOWEL FORCEPS132432022-11-22
B9741629004NEEDLE HOLDERMAYO HEGAR NEEDLE HOLDERS162902022-11-22
B9742370FORCEPSSPONGE FORCEPS2372022-11-22
B974256950EAR FORCEPSJANSEN EAR FORCEPS256952022-11-22
B9743290808NAIL NIPPERSNAIL NIPPERS 329082022-11-22
B97450524507FORCEPSDebakey Forceps5052452022-11-22
B9748112604OPERATING SCISSORSCVD 811262022-11-22
B974813100SCISSORSMAYO SCISSORS813102022-11-22
B9748148007SCISSORSSTRABISMUS SCISSORS814802022-11-22
B974814850SCISSORS STRABISMUS SCISSORS 814852022-11-22
B974818900FORCEPSPEAN FORCEPS818902022-11-22
B974AF25720S0EAR FORCEPSMICRO ALLIGATOR FORCEPSAF25720S2022-11-22
B974ATF8PAS0FORCEPSALLIS TISSUE FORCEPSATF8PAS2022-11-22
B974BES6PAS0SCISSORSEPISIOTOMY SCISSORSBES6PAS2022-11-22
B974BNH21906NEEDLE HOLDERBAUMGARTNER NEEDLE HOLDERBNH2192022-11-22
B974BTC17306TOWEL CLAMPTOWEL CLAMPBTC1732022-11-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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00348783006018Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006056Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006063Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006186Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
00348783006223Premier ExplorersPREMIER DENTAL PRODUCTS COMPANYEKB2026-03-17
G149TBSEXP111201TBS DentalACME ENTERPRISE.EKB2026-03-02
00840018673229Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-11
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00840018667150Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-10
00840018666108Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-09
00840018663688Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-04
00840018664012Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKB2026-02-04
08800019151548Endodontic ExplorerB& L Biotech, inc.EKB2025-04-30
EZPF2474460HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEKB2025-03-07
EZPF2474465HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEKB2025-03-07
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00889813065198Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
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00889813065228Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKB2024-11-30
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