FDA.report

Arthrex®

Primary DI
00888867427433
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-S7115-025-260
Catalog number
AR-S7115-025-260
Device description
Hook Scissors, 2.5 x 260mm
Published
2023-06-05
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

Product Codes

CodeName
HTXRONGEUR
LXHOrthopedic manual surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888867427433PrimaryGS10

GMDN Terms

TermDefinition
General-purpose surgical scissors, reusableA 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 reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags

DUNS number
131747628
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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