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AutoLap Sterile Drape

FDA UDI

Class II (US FDA UDI)

by M.s.t. Medical Surgery Technologies Ltd

Identity

Trade Name
AutoLap Sterile Drape FDA UDI
Generic Name
Surgical instrument assist arm system, power-adjusted FDA UDI
Model / Reference
ASS07018US FDA UDI

Identifiers

Primary DI / UDI-DI
17290016648246 FDA UDI
510(k) Number
K131375 FDA UDI
K152848 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Surgical instrument assist arm system, power-adjusted FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

AutoLap Sterile Drape by M.s.t. Medical Surgery Technologies Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K131375 also covers:

K152848 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
M.s.t. Medical Surgery Technologies Ltd

Sources (1)

  • FDA UDI fc53dee2-0b66-4ad8-9a84-dce8dfc47a5c 34 fields · synced Jun 8, 2026