FDA.reportPublic FDA data

Co-Axial Introducer Needle

Primary DI
10848782023735
Brand
Co-Axial Introducer Needle
Company
Surgical Specialties México, S. de R.L. de C.V.
Model
MCXS2015TM
Device description
Co-Axial Introducer Needle
Published
2016-09-20
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
KNWINSTRUMENT, BIOPSY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10848782023735PackageGS110In Commercial Distribution
00848782023738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084878202373510848782023735
00848782023738008487820237388487820237380848782023738

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge19Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)991-1110service@surgicalspecialties.com

Regulatory Flags#

DUNS number
812762226
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
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
10848782051516QuillVLP-4160 2025-07-11
00848782051786OnatecOL144091OL1440912025-06-02
00848782051793OnatecOL415691OL4156912025-06-02
00848782051809OnatecOL456291OL4562912025-06-02
10848782051813OnatecON456291ON4562912025-06-02
10848782051820OnatecON245071ON2450712025-06-02
10848782051837OnatecON146571ON1465712025-06-02
10848782051844OnatecON244081ON2440812025-06-02
10848782051851OnatecON454081ON4540812025-06-02
00848782051861OnatecOL145091OL1450912025-06-02
00848782051878OnatecOL415591OL4155912025-06-02
00848782051892OnatecOL145081OL1450812025-06-02
00848782051908OnatecOL415681OL4156812025-06-02
10848782051912OnatecOE261391OE2613912025-06-02
10848782051929OnatecOE471691OE4716912025-06-02
10848782051936OnatecON456671ON4566712025-06-02
10848782051943OnatecOE481691OE4816912025-06-02
10848782051950OnatecOE341331OE3413312025-06-02
00848782051960OnatecOL494891OL4948912025-06-02
00848782051977OnatecOL415592OL4155922025-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974405095210CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.KNW2026-05-26
06974405095227CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.KNW2026-05-26
06974405095067CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.KNW2026-05-25
00841911100508Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102281Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102458Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102489Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102496Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00841911102632Mammotome PrimaDEVICOR MEDICAL PRODUCTS, INC.KNW2026-03-13
00801741234187EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-09
10801741234153EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-04
10801741234160EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-04
00801741236167EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-04
00801741234194EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
00801741234248EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
00801741234262EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
00801741235221EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-02-03
10801741234092EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-30
10801741234139EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-30
00801741234200EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-30
10801741234115EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-28
10801741234146EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-28
10801741234177EnCor EnCompass™Bard Peripheral Vascular, Inc.KNW2026-01-28
10850075308016HYDRACELL-ORTHO-5RANFAC CORP.KNW2025-09-25
10850075308030HYDRACELL-ORTHO-10RANFAC CORP.KNW2025-09-25
10850075308047HYDRACELL-EXT-5RANFAC CORP.KNW2025-09-25
10850075308061HYDRACELL-EXT-10RANFAC CORP.KNW2025-09-25
08058983746639TRAP EASYH.S. HOSPITAL SERVICE SPAKNW2025-09-23
10810563022725OmniBone Bone Biopsy Kit with 11 Gauge 68mm lengthVARIAN MEDICAL SYSTEMS, INC.KNW2025-09-18
10810563022732OmniBone Bone Biopsy Kit with 11 Gauge 108mm lengthVARIAN MEDICAL SYSTEMS, INC.KNW2025-09-18