A.M.I.-dock Bluntdissect DLU 10mm

FDA UDI

Class I (US FDA UDI)

by AMI Agency for Medical Innovations GmbH

Identity

Trade Name: A.M.I.-dock Bluntdissect DLU 10mm FDA UDI
Generic Name: Dissection sponge FDA UDI
Device Name: Loading unit for blunt dissection for A.M.I.-dock Applicator 10mm. The Bluntdissect DLU`s are part of the A.M.I.-dock System which is a set of instruments intended for using during laparoscopic surgical procedures. The system consists of: - various A.M.I.-dock Applicators, delivered non sterile, - various A.M.I.-dock DLU’s (Disposable Loading Units), sterile packed, for different applications in the OR. FDA UDI
Model / Reference: A10 131 FDA UDI
Description: Loading unit for blunt dissection for A.M.I.-dock Applicator 10mm. The Bluntdissect DLU`s are part of the A.M.I.-dock System which is a set of instruments intended for using during laparoscopic surgical procedures. The system consists of: - various A.M.I.-dock Applicators, delivered non sterile, - various A.M.I.-dock DLU’s (Disposable Loading Units), sterile packed, for different applications in the OR. FDA UDI

Identifiers

Catalog Number: A10 131 FDA UDI
Primary DI / UDI-DI: EAMIA101310 FDA UDI
FDA Product Code: GDO FDA UDI
GMDN Term: Dissection sponge FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 28 Millimeter FDA UDI
Outer Diameter — 8 Millimeter FDA UDI

A.M.I.-dock Bluntdissect DLU 10mm by AMI Agency for Medical Innovations GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: AMI Agency for Medical Innovations GmbH

Sources (1)

FDA UDI e05a9fd9-9cd5-45e9-a16e-6a2c4a805b63 36 fields · synced Jun 1, 2026