Laser SWAB SS Tissue Handler And Backstop for Laser (non glare)

FDA UDI

Class I (US FDA UDI)

by Oculo-Plastik Inc

Identity

Trade Name: Laser SWAB SS Tissue Handler And Backstop for Laser (non glare) FDA UDI
Generic Name: Hand-held surgical retractor, reusable FDA UDI
Device Name: The Laser Swab is an instrument used in blepharoplasty at superior and inferior levels. It is used to grip and roll adipose (fat) tissue behind the eyelids. Facilitating excision of the fat with the laser. It is completely non-glare. FDA UDI
Model / Reference: 21-289 FDA UDI
Description: The Laser Swab is an instrument used in blepharoplasty at superior and inferior levels. It is used to grip and roll adipose (fat) tissue behind the eyelids. Facilitating excision of the fat with the laser. It is completely non-glare. FDA UDI

Identifiers

Primary DI / UDI-DI: 10697660001989 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Hand-held surgical retractor, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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Implantable

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Contains Latex

FDA UDI

Prescription Use

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

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Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 5.0 Millimeter FDA UDI
Outer Diameter — 6.5 Millimeter FDA UDI

Laser SWAB SS Tissue Handler And Backstop for Laser (non glare) by Oculo-Plastik Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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: Oculo-Plastik Inc

Sources (1)

FDA UDI 24c77546-6681-42aa-b4ed-32dee6a39419 36 fields · synced Jun 8, 2026