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gSource

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref gS 61.6380

by Gsource, Llc.

Identity

Trade Name
Nail Rasp #93 DE 6 3/4" 2mm angled up/down EUDAMED
gSource FDA UDI
Generic Name
Toenail file/rasp, single-use FDA UDI
Device Name
Scraping EUDAMED
Nail Rasp #93 DE 6 3/4" 2mm angled up/down FDA UDI
Model / Reference
gS 61.6380 EUDAMEDFDA UDI
Description
Nail Rasp #93 DE 6 3/4" 2mm angled up/down FDA UDI

Identifiers

Catalog Number
gS 61.6380 FDA UDI
Primary DI / UDI-DI
00840314232205 EUDAMEDFDA UDI
Basic UDI-DI
08403142SCRAPINGPD EUDAMED
Direct Marketing DI
00840314232205 EUDAMED
FDA Product Code
LXH FDA UDI
EMDN Code
L091201 ORTHOPAEDIC SURGERY RASPS, REUSABLE EUDAMED
GMDN Term
Toenail file/rasp, single-use FDA UDI

Classification

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

Yes

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

Category: Toenail file/rasp, single-use

gSource by Gsource, Llc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Toenail file/rasp, single-use.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gsource, Llc.

Sources (2)

  • FDA UDI 9e7639e1-50d3-444b-bdd1-62bce6bf5cd2 34 fields · synced Jul 25, 2026
  • EUDAMED 6251bbd3-70d5-4423-9828-a69aec8e6908 61 fields · synced Jul 25, 2026