FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403050138
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
GU4590-001
Catalog number
GU4590-001
Device description
"V. Mueller COBB-RAGDE NEEDLE 1 NEEDLE OVERALL LENGTH 10"" (25.4CM)"
Published
2018-08-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
10885403050138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540305013810885403050138

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct) to allow surgical intervention on those tissues. It is not primarily designed for pulling aside tissues for surgical access purposes (i.e., not a retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088Customer_Support@BD.com

Regulatory Flags#

DUNS number
832696038
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403057229JamshidiBAK4508BAK45082016-09-23
10885403057236JamshidiBAK4511BAK45112016-09-23
10885403057267JamshidiBEK4511BEK45112016-09-30
10885403075971PleurX50-7000B50-7000B2017-09-15
10885403076022Denver42-301942-30192017-06-12
10885403076046Denver42-900042-90002017-06-12
10885403107702JamshidiBCTM3411SPBCTM3411SP2016-09-30
10885403108365Safe-T-CentesisPIG1260TPIG1260T2018-07-18
10885403108389Safe-T-CentesisPIG1260TSPPIG1260TSP2018-07-18
10885403108402Safe-T-CentesisPIG1280TPIG1280T2018-07-18
10885403108426Safe-T-CentesisPIG1280TSPPIG1280TSP2018-07-18
10885403108433Safe-TTPT1000SPTPT1000SP2018-07-18
10885403108488NATPT1000TPT10002018-07-18
10885403108495Safe-TTPT1000SDFTPT1000SDF2018-07-18
10885403220852NATPT1005TPT10052018-07-18
10885403220869Safe-TTPT1005SPTPT1005SP2018-07-18
10885403228131Safe-TTPT1005SDFTPT1005SDF2018-07-18
10885403231780JamshidiBAK4511DFBAK4511DF2016-09-23
10885403231896Safe-T-CentesisPIG1260TCDFPIG1260TCDF2018-07-18
10885403231902NATPT1000CDFTPT1000CDF2018-07-18

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
00827002145191CookCOOK INCORPORATEDFHR2020-10-02
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