FDA.reportPublic FDA data

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
Single use
true

Product Codes#

Code, Name table
CodeName
EKBExplorer, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKBExplorer, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B974DEP500000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length158Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
645680125
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
B974122000FORCEPSPEAN FORCEPS122002022-11-22
B9742370FORCEPSSPONGE FORCEPS2372022-11-22
B974818900FORCEPSPEAN FORCEPS818902022-11-22
B974AF25720S0EAR FORCEPSMICRO ALLIGATOR FORCEPSAF25720S2022-11-22
B974ATF8PAS0FORCEPSALLIS TISSUE FORCEPSATF8PAS2022-11-22
B974CF818000FORCEPSCRILE FORCEPSCF818002022-11-22
B974CF818100FORCEPSCRILE FORCEPSCF818102022-11-22
B974CK80400FORCEPSKELLY FORCEPSCK80402022-11-22
B974EA5850FORCEPSPEAN FORCEPSEA5852022-11-22
B974EA6000FORCEPSSPONGE FORCEPS EA6002022-11-22
B974EA6100FORCEPSALLIS TISSUE FORCEPSEA6102022-11-22
B974EA610S02FORCEPSALLIS TISSUE FORCEPSEA610S2022-11-22
B974EA8560FORCEPSALLIS TISSUE FORCEPSEA8562022-11-22
B974FS95000FORCEPSSPONGE FORCEPSFS9502022-11-22
B974IF10560FORCEPSLOWA PUNCTURING FORCEPSIF10562022-11-22
B974IF2250FORCEPSUMBILICAL FORCEPSIF2252022-11-22
B974MHS1020HAEMOSTATIC FORCEPSMOSQUITO FORCEPSMHS1022022-11-22
B974MHS102FS0FORCEPSMOSQUITO FORCEPSMHS102FS2022-11-22
B974MHS102L0FORCEPSMOSQUITO FORCEPSMHS102L2022-11-22
B974MHS102S0FORCEPSMOSQUITO FORCEPSMHS102S2022-11-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G879102133H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102134H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
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G149TBSB2010TBS BASICSACME ENTERPRISE.EKB2026-05-16
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G149TBSB2050TBS BASICSACME ENTERPRISE.EKB2026-05-16
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G149TBSB3020TBS BASICSACME ENTERPRISE.EKB2026-05-16
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G149TBSB3040TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3050TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3060TBS BASICSACME ENTERPRISE.EKB2026-05-16
10889950002916HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
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