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Model 1680 Torque Wrench

FDA UDI

Class III (US FDA UDI)

by ReShape Lifesciences Inc.

Identity

Trade Name
Model 1680 Torque Wrench FDA UDI
Generic Name
Surgical torque wrench, reusable FDA UDI
Device Name
The Model 1680 Torque Wrench is a sterile standard surgical wrench provided for use during the implant procedure to tighten the set screws that secure the leads to the Rechargeable Neuroregulator. FDA UDI
Model / Reference
1680 FDA UDI
Description
The Model 1680 Torque Wrench is a sterile standard surgical wrench provided for use during the implant procedure to tighten the set screws that secure the leads to the Rechargeable Neuroregulator. FDA UDI

Identifiers

Catalog Number
1680 FDA UDI
Primary DI / UDI-DI
00857334004248 FDA UDI
PMA Number
P130019 FDA UDI
FDA Product Code
PIM FDA UDI
GMDN Term
Surgical torque wrench, reusable FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 1.685 Inch FDA UDI
Outer Diameter — 0.218 Inch FDA UDI

Model 1680 Torque Wrench by ReShape Lifesciences Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ReShape Lifesciences Inc.

Sources (1)

  • FDA UDI b4849c40-160c-448f-944e-350a3a511f32 39 fields · synced May 30, 2026