FDA.report

CLAMP CUTTER

Primary DI
B974CTR3500
Brand
CLAMP CUTTER
Company
DR.FRIGZ INTERNATIONAL(PVT)LTD,
Model
CORD CLAMP CUTTER
Catalog number
CTR350
Device description
CORD CLAMP CUTTER 4-3/4"
Published
2022-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KOHInstrument, Manual, General Obstetric-Gynecologic

Product Code Classifications

CodeDeviceSpecialtyClass
KOHInstrument, Manual, General Obstetric-GynecologicObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B974CTR3500PrimaryHIBCC0

GMDN Terms

TermDefinition
General-purpose surgical scissors, single-useA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a single-use device.

Device Sizes

TypeValueUnit
Length4.75Inch

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
645680125
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
true
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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