FDA.reportPublic FDA data

Arthrex®

Primary DI
M150ABS2000OT1
Brand
Arthrex®
Company
ARTHREX, INC.
Model
ABS-2000-OT
Catalog number
ABS-2000-OT
Device description
IOBP, Core Decompression and DeliveryKit
Published
2017-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867284876PrimaryGS10
M150ABS2000OT1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867284876008888672848768888672848760888867284876

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867460973Arthrex®AR-9001A-7140CSAR-9001A-7140CS2026-06-11
00888867179493Arthrex®AR-8835L-08SAR-8835L-08S2017-04-07
00888867186293Arthrex®AR-8835-08SAR-8835-08S2017-03-03
00888867202733Arthrex®AR-8948W-2045AR-8948W-20452017-02-25
00888867237612Arthrex®AR-8827L-08SAR-8827L-08S2017-05-11
00888867238602Arthrex®AR-1927PSF-475AR-1927PSF-4752017-05-05
00888867483927Arthrex®AR-4020C-06DAR-4020C-06D2025-11-06
00888867525924Arthrex®AR-7269RAR-7269R2025-10-20
00888867456174Arthrex®AR-3610NDF-1AR-3610NDF-12025-11-14
00888867456181Arthrex®AR-3610NDF-2AR-3610NDF-22025-11-14
00888867456198Arthrex®AR-3610NDF-3AR-3610NDF-32025-11-14
00888867456204Arthrex®AR-3610NDF-4AR-3610NDF-42025-11-14
00888867525931Arthrex®AR-7269R-1AR-7269R-12025-10-20
00888867465220Arthrex®AR-1588SBR-RTAR-1588SBR-RT2025-06-23
00888867465237Arthrex®AR-1588SBR-RT-IBAR-1588SBR-RT-IB2025-06-23
00888867465244Arthrex®AR-1588SBR-RT-IBRAR-1588SBR-RT-IBR2025-06-23
00888867501324Arthrex®AR-1588SBR-RTT-IBAR-1588SBR-RTT-IB2025-06-23
00888867501331Arthrex®AR-1588SBR-RTT-IBRAR-1588SBR-RTT-IBR2025-06-23
00888867458048Arthrex®AR-S1000-C4AR-S1000-C42024-01-23
00888867426023Arthrex®AR-3711AR-37112023-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593Polycarbonate syringe -DMC MEDICAL LIMITEDFMF2026-06-01
05391530753609Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01