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ReShape Lap-Band® 2.0, FLEX Tubing Kit

FDA UDI

Class III (US FDA UDI)

by ReShape Lifesciences Inc.

Identity

Trade Name
ReShape Lap-Band® 2.0, FLEX Tubing Kit FDA UDI
Generic Name
Gastric band repair kit FDA UDI
Device Name
ReShape Lap-Band® 2.0, FLEX Tubing Kit FDA UDI
Model / Reference
D-3500 FDA UDI
Description
ReShape Lap-Band® 2.0, FLEX Tubing Kit FDA UDI

Identifiers

Catalog Number
D-3500 FDA UDI
Primary DI / UDI-DI
00850007764586 FDA UDI
PMA Number
P000008 FDA UDI
FDA Product Code
LTI FDA UDI
GMDN Term
Gastric band repair kit FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Gastric band repair kit

ReShape Lap-Band® 2.0, FLEX Tubing Kit by ReShape Lifesciences Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P000008 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
ReShape Lifesciences Inc.

Sources (1)

  • FDA UDI 307dd0d2-40a0-49e8-bfdd-609b5e324e50 37 fields · synced Jun 8, 2026