FDA.report

Arthrex®

Primary DI
00888867516144
Company
ARTHREX, INC.
Model
AR-3210-0064
Catalog number
AR-3210-0064
Device description
250mm Nano Low Flow Sheath Kit
Published
2026-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
131747628
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00888867516144PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00888867516144PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
NBHAccessories, Arthroscopic1Orthopedic888.1100NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Arthroscopic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

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

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00888867529038Arthrex®AR-8827H-10AR-8827H-102026-03-16
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00888867529076Arthrex®AR-8827H-18AR-8827H-182026-03-16
00888867529083Arthrex®AR-8827H-20AR-8827H-202026-03-16
00888867529090Arthrex®AR-8827H-22AR-8827H-222026-03-16
00888867529106Arthrex®AR-8827H-24AR-8827H-242026-03-16
00888867529113Arthrex®AR-8827H-26AR-8827H-262026-03-16
00888867529120Arthrex®AR-8827H-28AR-8827H-282026-03-16
00888867529137Arthrex®AR-8827H-30AR-8827H-302026-03-16
00888867529144Arthrex®AR-8827H-32AR-8827H-322026-03-16

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