FDA.reportPublic FDA data

One-Tie

Primary DI
10827002319292
Brand
One-Tie
Company
Cook Vandergrift Inc.
Model
G31929
Catalog number
LR-OTE-N
Device description
One-Tie Compression Coil
Published
2023-07-06
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

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
10827002319292PackageGS15In Commercial Distribution
00827002319295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700231929210827002319292
00827002319295008270023192958270023192950827002319295

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead extraction wrapA sterile device intended to be used to aid the release and removal of a cut implantable pacemaker or implantable cardioverter-defibrillator (ICD) lead (hollow coil type) by binding the proximal components of the lead and/or other lead extraction/extension device (e.g., pacing lead stylet). It is typically in the form of a wire loop with handles intended to be wrapped around components for extraction. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
056867526
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00827002260573Cook FlexipetG26057K-FPIP-1600-10BS-52016-09-24
00827002267114Cook FlexipetG26711K-FPIP-1130-10BS-52016-09-24
00827002267121Cook FlexipetG26712K-FPIP-1140-10BS-52016-09-24
00827002267138Cook FlexipetG26713K-FPIP-1170-10BS-52016-09-24
00827002327955CookG32795K-EBPH-30352016-09-24
00827002327993CookG32799K-EBPH-35352016-09-24
00827002460171Cook FlexipetG46017K-FPIP-1300-102016-09-24
00827002460188Cook FlexipetG46018K-FPIP-1170-102016-09-24
00827002460195Cook FlexipetG46019K-FPIP-1140-102016-09-24
00827002460201Cook FlexipetG46020K-FPIP-1300-10BS-52016-09-24
00827002460218Cook FlexipetG46021K-FPIP-1120-10BS-52016-09-24
10827002188782Cook FlexipetG18878K-FPIP-1300-10BS2016-09-24
10827002261812Cook FlexipetG26181K-FPIP-1080-10BS2016-09-24
10827002267180Cook FlexipetG26718K-FPIP-1100-10BS2016-09-24
00827002609891COOKG60989K-EBPH-20302025-07-24
00827002610132COOKG61013K-EBPH-20352025-07-24
00827002610149COOKG61014K-EBPH-25302025-07-24
00827002610156COOKG61015K-EBPH-25352025-07-24
10827002609898COOKG60989K-EBPH-20302025-07-24
10827002610139COOKG61013K-EBPH-20352025-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661219527688DELACROIX-CHEVALIERLANDANGERDWS2026-09-27
00724995286651V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286668V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286675V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286682V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
10884389855416NAMICMEDLINE INDUSTRIES, INC.DWS2026-09-25
04058749012446NAFehling Instruments GmbH & Co. KGDWS2026-09-21
00192896123762TAVR Removal SetSONTEC INSTRUMENTS, INC.DWS2026-09-18
B040PHR10Premature Hinged Sternal RetractorGENESEE BIOMEDICAL, INC.DWS2026-09-18
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