FDA.reportPublic FDA data

MicroTransponder

Primary DI
10810041430158
Brand
MicroTransponder
Company
Microtransponder
Model
6001
Device description
Tunneling Tool
Published
2024-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
10810041430158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081004143015810810041430158

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
793502068
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
10810041430028Vivistim® 10012022-04-29
10810041430066Paired VNS30002022-04-29
10810041430080Paired VNS30002022-04-29
10810041430004Vivistim40012022-03-28
10810041430042Paired VNS20002022-03-28
10810041430141Paired VNS21002022-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00190776411558MillenniumAvalign Technologies, Inc.HAO2026-08-07
00190776407537MillenniumAvalign Technologies, Inc.HAO2026-08-03
00810220800508Adler Instrument CompanyAdler, Inc.HAO2026-07-30
00810220800515Adler Instrument CompanyAdler, Inc.HAO2026-07-30
00190776407377MillenniumAvalign Technologies, Inc.HAO2026-07-28
00190776407384MillenniumAvalign Technologies, Inc.HAO2026-07-28
00190776404109MillenniumAvalign Technologies, Inc.HAO2026-07-24
00190776404000MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404017MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404024MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404031MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404048MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404055MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404062MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404079MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776400262MillenniumAvalign Technologies, Inc.HAO2026-07-21
00190776400545MillenniumAvalign Technologies, Inc.HAO2026-07-19
00190776402105MillenniumAvalign Technologies, Inc.HAO2026-07-19
00190776400286MillenniumAvalign Technologies, Inc.HAO2026-07-17
04058749078794NAFehling Instruments GmbH & Co. KGHAO2026-07-17