FDA.reportPublic FDA data

Ball Probe

Primary DI
10840199533500
Brand
Ball Probe
Company
KOROS U.S.A., INC.
Model
7793-22
Catalog number
7793-22
Device description
Spetzer Type Angled Ball Probe 40 Degree
Published
2022-03-01
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
FZSCurette, Surgical, General Use
KAKProbe, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1
KAKProbe, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840199533503Direct MarkingGS10
10840199533500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199533503008401995335038401995335030840199533503
1084019953350010840199533500

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical probeA non-sterile, slender, rod-like, hand-held manual surgical instrument, typically made of metal, with an angled tip and a handle, designed for exploring/dissecting intracranial structures during a surgical procedure (e.g., tumour removal, third ventriculostomy, cyst fenestration). This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-805-529-0825customerservice@korosUSA.com

Regulatory Flags#

DUNS number
007928633
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

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10840199507723Separator7230-107230-102024-12-31
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10840199507778Elevator7230-307230-302024-12-31
10840199507785Elevator7230-357230-352024-12-31
10840199507792Elevator7230-407230-402024-12-31
10840199507808Elevator7230-427230-422024-12-31
10840199507815Elevator7230-437230-432024-12-31
10840199507877Elevator7230-607230-602024-12-31
10840199507907Hook7232-057232-052024-12-31

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Primary DI, Brand, Company table
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B382SD9147096450Surgical DirectSurgical Direct, Inc.FZS2026-07-09
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B382SD9147096510Surgical DirectSurgical Direct, Inc.FZS2026-07-09
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B382SD9147096530Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096540Surgical DirectSurgical Direct, Inc.FZS2026-07-09
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