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Lithium-Polymer Replacement Battery

FDA UDI

Class I (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name
LITHIUM-POLYMER REPLACEMENT BATTERY FDA UDI
Generic Name
Loupe FDA UDI
Device Name
LITHIUM-POLYMER REPLACEMENT BATTERY FOR MPACK UNPLUGGED FDA UDI
Model / Reference
X-007.99.680 FDA UDI
Description
LITHIUM-POLYMER REPLACEMENT BATTERY FOR MPACK UNPLUGGED FDA UDI

Identifiers

Catalog Number
X-007.99.680 FDA UDI
Primary DI / UDI-DI
00192896071742 FDA UDI
FDA Product Code
FSP FDA UDI
GMDN Term
Loupe FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Loupe

Lithium-Polymer Replacement Battery by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Loupe.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sontec Instruments, Inc.

Sources (1)

  • FDA UDI af332f25-01f3-4e30-be4e-0679db454055 35 fields · synced Jun 1, 2026