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Awl 7mm & 8mm

EUDAMEDFDA UDI

Class I (EU MDR)

Ref ATMWCIN43

by Abanza Tecnomed, S.l.

Identity

Trade Name
Awl 7mm & 8mm EUDAMEDFDA UDI
Generic Name
Bone awl, reusable FDA UDI
Device Name
Awl 7mm & 8mm EUDAMED
Used to insert the screw of the WasherCap™ Fixation System. FDA UDI
Model / Reference
ATMWCIN43 EUDAMED
21 FDA UDI
Description
Used to insert the screw of the WasherCap™ Fixation System. FDA UDI

Identifiers

Primary DI / UDI-DI
08437019739515 EUDAMEDFDA UDI
Basic UDI-DI
B-08437019739515 EUDAMED
FDA Product Code
HWJ FDA UDI
EMDN Code
L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term
Bone awl, reusable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
888.4540 FDA UDI
Market of Registration
Spain 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

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

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Awl 7mm & 8mm by Abanza Tecnomed, S.l. — Class I — 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
Abanza Tecnomed, S.l.
EUDAMED SRN
ES-MF-000007530

Sources (2)

  • EUDAMED 4615cdbf-c02f-4329-8f8e-485230294804 61 fields · synced Jun 18, 2026
  • FDA UDI 240d1a29-6d2c-4707-a6ad-e761ca3f96dc 34 fields · synced May 30, 2026