FDA.report

NA

Primary DI
00763000562793
Brand
NA
Company
MEDTRONIC, INC.
Model
6056M
Device description
LEAD ACC KIT 6056M GLBL MDR
Published
2023-11-10
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

Related Records

Contact Domains

Product Codes

CodeName
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00763000562793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000562793007630005627937630005627930763000562793

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
006261481
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DIBrandModelCatalogPublished
00763000764234NACB11Z66R2022-12-23
00763000764241NACB11Z68R2022-12-25
00763000764319NAHY2G71R92022-12-10
00763000764951NABB12A73R2022-12-08
00763000770419NA11Z79R12022-12-15
00763000770433NABB12B18R2022-12-15
00763000774127NABB11U49R32022-12-15
00763000791421NABB11Y57R52022-12-22
00763000810436NABB12A62R12022-12-23
00763000810610NABB7M96R182022-12-23
00763000810627NACB11Z63R2022-12-23
00763000811723NABB12A02R2022-12-26
00763000811754NABB7H85R262022-12-26
00763000811785NABB12A46R12022-12-26
00763000812126NAHY7W39R352022-12-31
00763000812133NABB12A69R12022-12-31
00763000812157NACB9E90R62022-12-31
00763000823580NAHY11W68R32023-01-14
00763000823597NAHY11N74R142023-01-14
00763000823795NAHY12A49R12023-01-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
24026704941593PILLINGTELEFLEX INCORPORATEDDWS2026-03-23
03661219509158DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511618DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511649DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511694DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511809DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511830DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219515425DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219515968DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528685DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528692DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528708DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528715DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219322184DELACROIX-CHEVALIERLANDANGERDWS2026-03-16
03661219323747DELACROIX-CHEVALIERLANDANGERDWS2026-03-13
04058749009538NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749009811NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749009873NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749009903NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043082NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043099NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043143NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043150NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749043167NAFehling Instruments GmbH & Co. KGDWS2026-03-05
04058749047752NAFehling Instruments GmbH & Co. KGDWS2026-03-05
00198506088957ELMED INCORPORATEDELMED INCORPORATEDDWS2026-03-03
03661219010296LANDANGERLANDANGERDWS2026-03-02
03661219138471DELACROIX-CHEVALIERLANDANGERDWS2026-03-02
03661219138518DELACROIX-CHEVALIERLANDANGERDWS2026-03-02
03661219138556DELACROIX-CHEVALIERLANDANGERDWS2026-03-02