FDA.report

Spinal Probe

Primary DI
00840199523399
Brand
Spinal Probe
Company
KOROS U.S.A., INC.
Model
7399-10
Catalog number
7399-10
Device description
Spinal Adjustable Length Probe 4mm, 26-42cm Length
Published
2021-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FZSCurette, Surgical, General Use

Product Code Classifications

CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840199523399Direct MarkingGS10
10840199523396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840199523399008401995233998401995233990840199523399
1084019952339610840199523396

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Store in dry place at room temperature

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-805-529-0825customerservice@korosUSA.com

Regulatory Flags

DUNS number
007928633
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
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
00840199528837Comfort Plus Chisel7540-067540-062025-01-31
00840199507726Separator7230-107230-102024-12-31
00840199507733Separator7230-157230-152024-12-31
00840199507740Elevator7230-187230-182024-12-31
00840199507757Elevator7230-207230-202024-12-31
00840199507764Elevator7230-257230-252024-12-31
00840199507771Elevator7230-307230-302024-12-31
00840199507788Elevator7230-357230-352024-12-31
00840199507795Elevator7230-407230-402024-12-31
00840199507801Elevator7230-427230-422024-12-31
00840199507818Elevator7230-437230-432024-12-31
00840199507870Elevator7230-607230-602024-12-31
00840199507900Hook7232-057232-052024-12-31
00840199507917Hook7232-107232-102024-12-31
00840199507924Hook7232-157232-152024-12-31
00840199507962Elevator7232-287232-282024-12-31
00840199507979Vein Retractor7232-307232-302024-12-31
00840199507986Vein Retractor7232-357232-352024-12-31
00840199507993Vein Retractor7232-407232-402024-12-31
00840199511426Chisel7315-217315-212024-12-31

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
M93071015043S20Life Instruments Life Instrument CorporationFZS2026-03-23
M93071015044S20Life InstrumentsLife Instrument CorporationFZS2026-03-23
04052536215539tezoUlrich GmbH & Co. KGFZS2026-03-16
04052536215546tezoUlrich GmbH & Co. KGFZS2026-03-16
00810130207367MSIModern Surgical Instruments LLCFZS2026-03-12
00810130207374MSIModern Surgical Instruments LLCFZS2026-03-12
00810130207381MSIModern Surgical Instruments LLCFZS2026-03-12
00810130207398MSIModern Surgical Instruments LLCFZS2026-03-12
04052536017560tezoUlrich GmbH & Co. KGFZS2026-03-12
04052536017577tezoUlrich GmbH & Co. KGFZS2026-03-12
04052536017584tezoUlrich GmbH & Co. KGFZS2026-03-12
04052536017751tezoUlrich GmbH & Co. KGFZS2026-03-12
00810158219182PRINCETONPrinceton Medical Group, Inc.FZS2026-03-11
00810158219199PRINCETONPrinceton Medical Group, Inc.FZS2026-03-11
M93071015043SAT20Life InstrumentsLife Instrument CorporationFZS2026-03-06
M93071015044SAT20Life InstrumentsLife Instrument CorporationFZS2026-03-06
00810158218802PRINCETONPrinceton Medical Group, Inc.FZS2026-02-05
04059453143389Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFZS2026-02-02
M9307120160110Life Instruments Life Instrument CorporationFZS2026-02-02
00810158218598PRINCETONPrinceton Medical Group, Inc.FZS2026-01-16
00810158218604PRINCETONPrinceton Medical Group, Inc.FZS2026-01-16
00841731142474Hintermann Series VILEX LLCFZS2026-01-16
00810158218505PRINCETONPrinceton Medical Group, Inc.FZS2026-01-15
M930712150000Life InstrumentsLife Instrument CorporationFZS2026-01-09
M930712150010Life InstrumentsLife Instrument CorporationFZS2026-01-09
M9307121501110Life InstrumentsLife Instrument CorporationFZS2026-01-09
M930712150200Life InstrumentsLife Instrument CorporationFZS2026-01-09
M930712150210Life InstrumentsLife Instrument CorporationFZS2026-01-09
M930712150300Life InstrumentsLife Instrument CorporationFZS2026-01-09
M930712150310Life InstrumentsLife Instrument CorporationFZS2026-01-09