FDA.report

WESCOTT TENOTOMY SCISSORS

Primary DI
00192896089402
Brand
WESCOTT TENOTOMY SCISSORS
Company
SONTEC INSTRUMENTS, INC.
Model
13-3400Q
Catalog number
13-3400Q
Device description
WESTCOTT TENOTOMY SCISSORS BLUNT CURVED BLADE
Published
2019-05-10
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
HNFScissors, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896089402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896089402001928960894021928960894020192896089402

GMDN Terms

TermDefinition
Ophthalmic suture scissorsA hand-held ophthalmic surgical instrument used to cut suture during eye surgery. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the fine blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes. This is a reusable device.

Device Sizes

TypeValueUnit
Length4.5Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts

PhoneEmail
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
true
Sterilization required before use
true

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