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Osyfibre

FDA UDI

Class II (US FDA UDI)

by LSO Medical

Identity

Trade Name
OSYFIBRE FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
STERILE MEDICAL OPTICAL FIBER FOR SINGLE USE FDA UDI
Model / Reference
PH-EO-980-25-600-3 FDA UDI
Description
STERILE MEDICAL OPTICAL FIBER FOR SINGLE USE FDA UDI

Identifiers

Primary DI / UDI-DI
03760227850150 FDA UDI
510(k) Number
K080731 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 1040 Micrometer FDA UDI
Lumen/Inner Diameter — 600 Micrometer FDA UDI
Length — 3 Meter FDA UDI

Category: General surgical procedure kit, non-medicated, single-use

Osyfibre by LSO Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LSO Medical

Sources (1)

  • FDA UDI 506a3d50-d250-43c4-89f3-befd509dde26 37 fields · synced Jun 6, 2026