FDA.reportPublic FDA data

Helix Locking Tool

Primary DI
00810024670291
Brand
Helix Locking Tool
Company
CENTERPOINT SYSTEMS LLC
Model
5616
Published
2024-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810024670291PrimaryGS10
10810024670298Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810024670291008100246702918100246702910810024670291
1081002467029810810024670298

GMDN Terms#

Term, Definition table
TermDefinition
Torque manipulation deviceA sterile hand-operated device intended to be attached to the proximal end of an invasive device (e.g., a catheter, a needle, or a guidewire) to provide the operator with the ability to manually manipulate and control the directional torque (rotation) of the device to which it is attached. This device may be made of plastic or metal materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-848-0828info@centerpoint-systems.com

Regulatory Flags#

DUNS number
117126091
Device count
2
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810024672011CPS Locator 3D Plus, Medium Delivery CatheterDS5D200-42DS5D200-422026-08-04
00810024672028CPS Locator 3D Plus, Large Delivery CatheterDS5D300-42DS5D300-422026-08-04
00810024672035CPS Locator 3D Plus, Extra Large Delivery CatheterDS5D400-42DS5D400-422026-08-04
00810024672042CPS Locator 3D Plus, Medium Delivery CatheterDS5D200-45DS5D200-452026-08-04
00810024672059CPS Locator 3D Plus, Large Delivery CatheterDS5D300-45DS5D300-452026-08-04
00810024672066CPS Locator 3D Plus, Extra Large Delivery CatheterDS5D400-45DS5D400-452026-08-04
00810024672196CPS Locator 3D Plus, Medium Delivery CatheterDS5D200-48DS5D200-482026-08-04
00810024672202CPS Locator 3D Plus, Large Delivery CatheterDS5D300-48DS5D300-482026-08-04
00810024672219CPS Locator 3D Plus, Extra Large Delivery CatheterDS5D400-48DS5D400-482026-08-04
00810024672554AuST Steerable SheathADS-MD-0029572026-08-06
00810024672561AuST Steerable SheathADS-MD-0029582026-08-06
00810024672578AuST Steerable SheathADS-MD-0029592026-08-06
00810024672585AuST Steerable SheathADS-MD-0029602026-08-06
00810024672592AuST Steerable SheathADS-MD-0029612026-08-06
00810024672608AuST Steerable SheathADS-MD-0029622026-08-06
00810024672615AuST Steerable SheathADS-MD-0029632026-08-06
00810024672622AuST Steerable SheathADS-MD-0029642026-08-06
00810024672639AuST Steerable SheathADS-MD-0029652026-08-06
00810024672646AuST Steerable SheathADS-MD-0029662026-08-06
00810024672653AuST Steerable SheathADS-MD-0029672026-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429119MillenniumAvalign Technologies, Inc.DWS2026-09-04
00884450456217Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456224Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456231Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
04058749008944NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749012521NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749036350NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749122626NAFehling Instruments GmbH & Co. KGDWS2026-09-04
00190776423933MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776423971MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776424114MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776424138MillenniumAvalign Technologies, Inc.DWS2026-08-27
00884450450970Merit Medical®Merit Medical Systems, Inc.DWS2026-08-27
00190776419707MillenniumAvalign Technologies, Inc.DWS2026-08-25
00190776420284MillenniumAvalign Technologies, Inc.DWS2026-08-25
00190776420390MillenniumAvalign Technologies, Inc.DWS2026-08-25
04058749004496NAFehling Instruments GmbH & Co. KGDWS2026-08-25
00190776417130MillenniumAvalign Technologies, Inc.DWS2026-08-19
00190776416973MillenniumAvalign Technologies, Inc.DWS2026-08-18
00190776417000MillenniumAvalign Technologies, Inc.DWS2026-08-18
00198506094064ELMED INCORPORATEDELMED INCORPORATEDDWS2026-08-18
00190776411107MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776411473MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776411497MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776411510MillenniumAvalign Technologies, Inc.DWS2026-08-07
00190776408732MillenniumAvalign Technologies, Inc.DWS2026-08-03
03661219141778DELACROIX-CHEVALIERLANDANGERDWS2026-08-02
03661219141785DELACROIX-CHEVALIERLANDANGERDWS2026-08-02
14026704916679PILLINGTELEFLEX INCORPORATEDDWS2026-08-01
00190776407438MillenniumAvalign Technologies, Inc.DWS2026-07-31