FDA.report

SONTEC BARRAQUER NEEDLE HOLDER

Primary DI
00192896018174
Brand
SONTEC BARRAQUER NEEDLE HOLDER
Company
SONTEC INSTRUMENTS, INC.
Model
T15-4120
Catalog number
T15-4120
Device description
SONTEC BARRAQUER NEEDLE HOLDER WITH LOCK EXTRA DELICATE CURVED JAW KNURLED HANDLE 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
HCFINSTRUMENT, LIGATURE PASSING AND KNOT TYING

Product Code Classifications

CodeDeviceSpecialtyClass
HCFInstrument, Ligature Passing And Knot TyingGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896018174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896018174001928960181741928960181740192896018174

GMDN Terms

TermDefinition
Needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Device Sizes

TypeValueUnit
Length4.875Inch

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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