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GoldenDent

FDA UDI

Class II (US FDA UDI)

by 3d Dental Designs And Development, Llc

Identity

Trade Name
GoldenDent FDA UDI
Generic Name
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI
Device Name
Coated Polyglycolic Acid (PGA) Braided Absorbable Suture Violet, 4-0, 19mm, 3/8 reverse cutting needle, FDA UDI
Model / Reference
SPGA4 FDA UDI
Description
Coated Polyglycolic Acid (PGA) Braided Absorbable Suture Violet, 4-0, 19mm, 3/8 reverse cutting needle, FDA UDI

Identifiers

Primary DI / UDI-DI
00817169022657 FDA UDI
FDA Product Code
GAM FDA UDI
GMDN Term
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4493 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Category: Polyester suture, bioabsorbable, multifilament, non-antimicrobial

GoldenDent by 3d Dental Designs And Development, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyester suture, bioabsorbable, multifilament, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3d Dental Designs And Development, Llc

Sources (1)

  • FDA UDI 9c87729e-9e42-45d9-aea7-4d413b08cd3e 33 fields · synced May 31, 2026