FDA.report

LOCKHART MUMMERY FISTULA PROBE

Primary DI
00192896017474
Brand
LOCKHART MUMMERY FISTULA PROBE
Company
SONTEC INSTRUMENTS, INC.
Model
15-0231
Catalog number
15-0231
Device description
LOCKHART MUMMERY FISTULA PROBE CURVED EYE HOLE TIP #2
Published
2018-09-13
Public version status
Update
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
FGMProbe And Director, Gastro-Urology

Product Code Classifications

CodeDeviceSpecialtyClass
FGMProbe And Director, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896017474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896017474001928960174741928960174740192896017474

GMDN Terms

TermDefinition
Gastro-urological probeA slender, rod-like, hand-held manual surgical instrument, typically made of flexible metal with a blunt bulbous tip, designed for exploring gastroenterological/urological (GU) structures during a GU procedure. This is a reusable device.

Device Sizes

TypeValueUnit
Length6.5Inch

Sterilization Methods

Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800) 821-7496info@sontecinstruments.com

Regulatory Flags

DUNS number
040729840
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
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

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