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Bacastow Arthroscopic Deltoid Lift Retractor

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 5081

by Innomed, Inc.

Identity

Trade Name
Bacastow Arthroscopic Deltoid Lift Retractor EUDAMED
Innomed, Inc. FDA UDI
Generic Name
Hand-held surgical retractor, reusable FDA UDI
Device Name
Retractor EUDAMED
Barcastow Arthroscopic Deltoid Lift Retractor FDA UDI
Model / Reference
5081 EUDAMEDFDA UDI
Description
Barcastow Arthroscopic Deltoid Lift Retractor FDA UDI

Identifiers

Catalog Number
5081 FDA UDI
Primary DI / UDI-DI
00840277113726 EUDAMEDFDA UDI
Basic UDI-DI
8402771INNORETRACT016A EUDAMED
Direct Marketing DI
00840277113726 EUDAMED
FDA Product Code
GAD FDA UDI
EMDN Code
L0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE EUDAMED
GMDN Term
Hand-held surgical retractor, reusable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
878.4800 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Bacastow Arthroscopic Deltoid Lift Retractor by Innomed, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Innomed, Inc.
EUDAMED SRN
US-MF-000014761
Authorised Representative
MediMark Europe Sarl. FR-AR-000000182

Sources (2)

  • EUDAMED cba8acac-9347-4640-a76f-d7b3d45f1a49 61 fields · synced Jun 17, 2026
  • FDA UDI 12f0f85e-92a9-4f47-99a9-e20f22894e48 34 fields · synced May 30, 2026