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Mammotome

FDA UDI

Class II (US FDA UDI)

by Devicor Medical Products, Inc.

Identity

Trade Name
Mammotome FDA UDI
Generic Name
Patient surgical drape, single-use, non-sterile FDA UDI
Device Name
DISPOSABLE DRAPE FDA UDI
Model / Reference
DL617 FDA UDI
Description
DISPOSABLE DRAPE FDA UDI

Identifiers

Primary DI / UDI-DI
00841911101284 FDA UDI
FDA Product Code
KKX FDA UDI
GMDN Term
Patient surgical drape, single-use, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Patient surgical drape, single-use, non-sterile

Mammotome by Devicor Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient surgical drape, single-use, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Devicor Medical Products, Inc.

Sources (1)

  • FDA UDI bf219e5c-3419-420e-80bd-4be5b5954cc0 34 fields · synced Jun 8, 2026