Sharpoint

FDA UDI

Class I (US FDA UDI)

by Surgical Specialties México, S. de R.L. de C.V.

Identity

Trade Name: Sharpoint FDA UDI
Generic Name: Scalpel, single-use FDA UDI
Device Name: Polyviolene, 2-0, 30", V-7, 1/2C Tapercut Cardio 26mm FDA UDI
Model / Reference: J8975D FDA UDI
Description: Polyviolene, 2-0, 30", V-7, 1/2C Tapercut Cardio 26mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00848782025404 FDA UDI
FDA Product Code: HNN FDA UDI
GMDN Term: Scalpel, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 FDA UDI
Commercial Distribution: 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

FDA UDI

Category: Scalpel, single-use

Sharpoint by Surgical Specialties México, S. de R.L. de C.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Surgical Specialties México, S. de R.L. de C.V.

Sources (1)

FDA UDI c5514755-13d5-4545-ad97-81430682877f 35 fields · synced Jun 6, 2026