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TrollBag

FDA UDI

Class I (US FDA UDI)

by Directa AB

Identity

Trade Name
TrollBag FDA UDI
Generic Name
Medical equipment/instrument drape, single-use FDA UDI
Model / Reference
BarrierSleeve for syringes FDA UDI

Identifiers

Catalog Number
507001 FDA UDI
Primary DI / UDI-DI
17310235070014 FDA UDI
FDA Product Code
EGZ FDA UDI
GMDN Term
Medical equipment/instrument drape, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.1905 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

TrollBag by Directa AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Directa AB

Sources (1)

  • FDA UDI cccbce5f-2515-43b1-b2c9-f5f4c8a1a6d0 34 fields · synced May 30, 2026