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Adler MircroMed Laser Surgery Fiber

FDA UDI

Class II (US FDA UDI)

by Adler MicroMed, Inc.

Identity

Trade Name
Adler MircroMed Laser Surgery Fiber FDA UDI
Generic Name
General/multiple surgical laser system beam guide, reusable FDA UDI
Device Name
Adler MircroMed laser Surgery Fiber 3.0 NC 270 HGT 420 FDA UDI
Model / Reference
BFCS000288 FDA UDI
Description
Adler MircroMed laser Surgery Fiber 3.0 NC 270 HGT 420 FDA UDI

Identifiers

Catalog Number
BFCS000288 FDA UDI
Primary DI / UDI-DI
00850348007182 FDA UDI
510(k) Number
K152417 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
General/multiple surgical laser system beam guide, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Adler MircroMed Laser Surgery Fiber by Adler MicroMed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K152417 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Adler MicroMed, Inc.

Sources (1)

  • FDA UDI db2d5ee9-65bf-41ff-aa4c-5aea1a2c13a3 36 fields · synced May 30, 2026