FDA.reportPublic FDA data

Model 2004 Maestro Implant Kit

Primary DI
00857334004279
Brand
Model 2004 Maestro Implant Kit
Company
Reshape Lifesciences Inc.
Model
2004
Catalog number
2004
Device description
The Model 2004 Implant Kit consists of a Model 2002 Rechargeable Neuroregulator (including Model 1680 Torque Wrench), a Model 2200P-47E Maestro Posterior Lead, and a Model 2200A-47E Anterior Lead packaged together.
Published
2015-04-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PIMneuromodulator for obesity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIMNeuromodulator For ObesityUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P130019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P130019000MAESTRO RECHARGEABLE SYSTEMReshape Lifesciences, Inc.2015-01-14PIM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857334004279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857334004279008573340042798573340042790857334004279

GMDN Terms#

Term, Definition table
TermDefinition
Gastric contractility modulation systemAn assembly of devices designed to improve glycaemic control and induce weight loss in obese patients with type 2 diabetes mellitus by monitoring intrinsic electrical and mechanical gastric activity and delivering gastric contractility modulation (GCM) signals to the stomach to provoke an early response of a full meal. It typically includes a battery-powered implantable pulse generator that produces GCM electrical stimuli delivered via implantable leads, an external programmer that enables healthcare personnel to telemetrically modify the GCM signal parameters of the pulse generator, an external charger to recharge the pulse-generator battery, a shadow data recorder, and a patient wand.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal150 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(651)789-2681lpritchard@enteromedics.com

Regulatory Flags#

DUNS number
144998551
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007764173LAP-BAND® System Calibration TubeB-2017B-20172020-12-01
00850007764210GIBI HDB-2032B-20322022-08-07
00850007764227GIBI HDB-2036B-20362022-08-07
00850007764234GIBI HDB-2040B-20402022-08-07
00857334004194Model 1600 Maestro Programmer Cable160016002015-04-17
00857334004200Model 1620 AC Recharger162016202015-04-17
00857334004217Model 1660 Maestro Patient Transmit Coil Belt166016602015-04-17
00857334004248Model 1680 Torque Wrench168016802015-04-17
00857334004262Model 2002 Maestro Rechargeable Neuroregulator200220022015-04-17
00857334004286Model 2200A-47E Maestro Anterior Lead2200A-47E2200A-47E2015-04-17
00857334004293Model 2200P-47E Maestro Posterior Lead2200P-47E2200P-47E2015-04-17
00857334004309Model 2402 Maestro Mobile Charger240224022015-04-17
00857334004316Model 2403-300 Maestro Clinician Transmit Coil2403-3002403-3002015-04-17
00857334004323Model 2403-60 Maestro Patient Transmit Coil2403-602403-602015-04-17
00857334004347Model 2404 Maestro Patient Kit240424042015-04-17
00857334004354Model 2502 Maestro Clinician Programmer250225022015-04-17
00857334004361Model 2504 Maestro Clinician Programmer Kit250425042015-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857334004194Model 1600 Maestro Programmer CableReshape Lifesciences Inc.PIM2015-04-17
00857334004200Model 1620 AC RechargerReshape Lifesciences Inc.PIM2015-04-17
00857334004217Model 1660 Maestro Patient Transmit Coil BeltReshape Lifesciences Inc.PIM2015-04-17
00857334004248Model 1680 Torque WrenchReshape Lifesciences Inc.PIM2015-04-17
00857334004262Model 2002 Maestro Rechargeable NeuroregulatorReshape Lifesciences Inc.PIM2015-04-17
00857334004286Model 2200A-47E Maestro Anterior LeadReshape Lifesciences Inc.PIM2015-04-17
00857334004293Model 2200P-47E Maestro Posterior LeadReshape Lifesciences Inc.PIM2015-04-17
00857334004309Model 2402 Maestro Mobile ChargerReshape Lifesciences Inc.PIM2015-04-17
00857334004316Model 2403-300 Maestro Clinician Transmit CoilReshape Lifesciences Inc.PIM2015-04-17
00857334004323Model 2403-60 Maestro Patient Transmit CoilReshape Lifesciences Inc.PIM2015-04-17
00857334004347Model 2404 Maestro Patient KitReshape Lifesciences Inc.PIM2015-04-17
00857334004354Model 2502 Maestro Clinician ProgrammerReshape Lifesciences Inc.PIM2015-04-17
00857334004361Model 2504 Maestro Clinician Programmer KitReshape Lifesciences Inc.PIM2015-04-17