FDA.reportPublic FDA data

SenSight™

Primary DI
00199150032426
Brand
SenSight™
Company
MEDTRONIC, INC.
Model
B31030-D
Device description
ACCY B31030-D EXT TNLR DUAL EMAN LP99
Published
2026-09-28
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
HAOINSTRUMENT, SURGICAL, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199150032426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199150032426001991500324261991500324260199150032426

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
968552153
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02
00643169014107INPUT™ PS0900232017-02-02
00643169014121INPUT™ PS8933112017-02-02
00643169014138INPUT™ PS8833112017-02-03
00643169014145INPUT™ PS8733112017-02-03
00643169014152INPUT™ PS8633112017-02-02
00643169014169INPUT™ PS8533112017-02-02
00643169014176NA6933112016-08-20
00643169014213NA6633112017-02-02
00643169014220NA6533112017-02-02
00643169014237INPUT™ PS5933112017-02-03
00643169014244INPUT™ PS5833112017-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995301934V. MuellerSteris CorporationHAO2026-10-21
00724995301958V. MuellerSteris CorporationHAO2026-10-21
00724995301972V. MuellerSteris CorporationHAO2026-10-21
00724995301989V. MuellerSteris CorporationHAO2026-10-21
00724995301996V. MuellerSteris CorporationHAO2026-10-21
00724995302214V. MuellerSTERIS Deutschland GmbHHAO2026-10-21
00724995303761V. MuellerSTERIS Deutschland GmbHHAO2026-10-21
00724995303853V. MuellerSTERIS Deutschland GmbHHAO2026-10-21
00724995303860V. MuellerSTERIS Deutschland GmbHHAO2026-10-21
04058749126471NAFehling Instruments GmbH & Co. KGHAO2026-10-12
00190776436551MilleniumAvalign Technologies, Inc.HAO2026-10-08
00190776436568MilleniumAvalign Technologies, Inc.HAO2026-10-08
00190776436575MilleniumAvalign Technologies, Inc.HAO2026-10-08
00190776436582MilleniumAvalign Technologies, Inc.HAO2026-10-08
00190776434427MillenniumAvalign Technologies, Inc.HAO2026-10-07
00190776434434MillenniumAvalign Technologies, Inc.HAO2026-10-07
00190776434342MillenniumAvalign Technologies, Inc.HAO2026-10-06
00199150032402SenSight™MEDTRONIC, INC.HAO2026-09-28
00724995303884V. MuellerSTERIS Deutschland GmbHHAO2026-09-25
04058749076042NAFehling Instruments GmbH & Co. KGHAO2026-09-21
00190776429126MillenniumAvalign Technologies, Inc.HAO2026-09-04
00190776423964MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776423995MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428068MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428075MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428082MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428099MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428105MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428112MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776420352MillenniumAvalign Technologies, Inc.HAO2026-08-25