FDA.report

VASECTOMY HOOK

Primary DI
00192896045552
Brand
VASECTOMY HOOK
Company
SONTEC INSTRUMENTS, INC.
Model
516-715T
Catalog number
516-715T
Device description
VASECTOMY HOOK SHARP TIP TITANIUM
Published
2018-09-14
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
GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GDGHook, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896045552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896045552001928960455521928960455520192896045552

GMDN Terms

TermDefinition
Spermatic cord hookA hand-held, surgical instrument used for hooking the spermatic cord (the cord-like structure consisting of the vas deferens and its accompanying arteries, veins, nerves and lymphatic vessels) in order to grasp it during a surgical procedure, e.g., a vasectomy. It is typically a shaft-like instrument with a bulbous, blunted, single hook at the distal end and a handle at the proximal end. It is made of high-grade stainless steel. This is a reusable device.

Device Sizes

TypeValueUnit
Length5.25Inch

Sterilization Methods

Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800) 821-7496info@sontecinstruments.com
+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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00192896122888Dissector2900-2332900-2332026-03-19
00192896122895Ball Dissector2900-2352900-2352026-03-19
00192896122901Hook Dissector2900-2372900-2372026-03-19
00192896122918Hook Dissector2900-2382900-2382026-03-19
00192896122925Spatula Dissector2900-2422900-2422026-03-19
00192896122932Spatula Dissector2900-2442900-2442026-03-19
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