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Diamatrix

FDA UDI

Class I (US FDA UDI)

by Diamatrix

Identity

Trade Name
Diamatrix FDA UDI
Generic Name
Eyelid speculum, reusable FDA UDI
Device Name
Jaffe Lid Retractor .035'' Stainless Wire, 15mm Closed Blade with curved shafts, 2 pieces per set, 55mm Overall Length FDA UDI
Model / Reference
W47-15 FDA UDI
Description
Jaffe Lid Retractor .035'' Stainless Wire, 15mm Closed Blade with curved shafts, 2 pieces per set, 55mm Overall Length FDA UDI

Identifiers

Catalog Number
W47-15 FDA UDI
Primary DI / UDI-DI
00813059016614 FDA UDI
FDA Product Code
HNC FDA UDI
GMDN Term
Eyelid speculum, reusable 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

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Eyelid speculum, reusable

Diamatrix by Diamatrix — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Eyelid speculum, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diamatrix

Sources (1)

  • FDA UDI 5bb6fdbc-6896-44c2-b77e-4f97578ca36e 34 fields · synced May 30, 2026