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Uniqcot

EUDAMEDFDA UDI

Class III (EU MDR)

Ref 67-07

by American Surgical Company, LLC

Identity

Trade Name
Uniqcot EUDAMEDFDA UDI
Generic Name
Neurosurgical sponge FDA UDI
Device Name
Uniqcot EUDAMED
Uniqcot 1/2" x 1" FDA UDI
Model / Reference
67-07 EUDAMEDFDA UDI
Description
Uniqcot 1/2" x 1" FDA UDI

Identifiers

Primary DI / UDI-DI
10749915001388 EUDAMED
20749915001385 FDA UDI
Basic UDI-DI
B-10749915001388 EUDAMED
510(k) Number
K902921 FDA UDI
FDA Product Code
HBA FDA UDI
EMDN Code
M040799 SPECIAL PADS - OTHER EUDAMED
GMDN Term
Neurosurgical sponge FDA UDI

Classification

Device Class
Class III EUDAMED
Class II FDA UDI
Regulation Number
882.4700 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

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

No

FDA UDI

Uniqcot by American Surgical Company, LLC — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
American Surgical Company, LLC
EUDAMED SRN
US-MF-000007259
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED 22d1f19f-41f7-4ed3-b3ed-0a79f1d5a1e9 61 fields · synced Jun 9, 2026
  • FDA UDI 144578af-ec9c-48b5-bae4-4771fa8616aa 34 fields · synced May 30, 2026