FDA.reportPublic FDA data

Cook

Primary DI
00827002145191
Brand
Cook
Company
COOK INCORPORATED
Model
G14519
Catalog number
090070
Device description
Fascial Incising Needle Use with wire guide .038
Published
2020-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHRNEEDLE, GASTRO-UROLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHRNeedle, Gastro-UrologyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002145191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002145191008270021451918270021451910827002145191

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, reusableA hand-held manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The device is typically made of high-grade stainless steel alloy. This is a reusable 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
042823948
Device count
1
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
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770413867Bausch + LombBausch & Lomb IncorporatedFHR2025-08-18
00757770425150Bausch + LombBausch & Lomb IncorporatedFHR2025-08-18
10810235030638"Rigid Needle 21 GA x 0.5"" (0,8 x 13 mm)"MERZ NORTH AMERICA, INC.FHR2024-10-21
00190776329549MILLENNIUMAvalign Technologies, Inc.FHR2023-09-28
00190776248659AvalignAvalign Technologies, Inc.FHR2023-06-23
14026704791665PILLINGTELEFLEX INCORPORATEDFHR2022-12-08
54026704791663PILLINGTELEFLEX INCORPORATEDFHR2022-12-08
00827002537408CookCOOK INCORPORATEDFHR2020-10-02
10885403205293V. MuellerSTERIS CORPORATIONFHR2018-09-17
10885403205309V. MuellerSTERIS CORPORATIONFHR2018-09-17
10885403205316V. MuellerSTERIS CORPORATIONFHR2018-09-17
10885403050725V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050732V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050336V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050343V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050350V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050121V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050138V. MuellerCAREFUSION 2200, INCFHR2018-08-30