FDA.report

Arthrex®

Primary DI
00888867317543
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-8978DS-01-1
Catalog number
AR-8978DS-01-1
Device description
Disp Kit for DX Swivelock SL, 3.5x8.5 mm
Published
2019-09-12
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

Contact Domains

Product Codes

CodeName
MBIFastener, fixation, nondegradable, soft tissue

Product Code Classifications

CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888867317543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867317543008888673175438888673175430888867317543

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.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
131747628
Device count
1
DM exempt
false
Premarket exempt
false
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

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00888867519503Arthrex®AR-8974TAR-8974T2026-03-16
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00888867529038Arthrex®AR-8827H-10AR-8827H-102026-03-16
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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
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