FDA.report

Arthrex®

Primary DI
00888867427914
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-S7116-040-260
Catalog number
AR-S7116-040-260
Device description
Scissor Punch, 4.0 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

Contact Domains

Product Codes

CodeName
HTXRONGEUR
LXHOrthopedic manual surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888867427914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867427914008888674279148888674279140888867427914

GMDN Terms

TermDefinition
Rigid endoscopic biopsy forceps, reusableA rigid, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., laparoscopy, thoracoscopy, spinoscopy, arthroscopy). It is typically constructed as a long instrument with one sliding and one stationary rod whose distal ends are equipped with scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. 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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00888867529113Arthrex®AR-8827H-26AR-8827H-262026-03-16
00888867529120Arthrex®AR-8827H-28AR-8827H-282026-03-16
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