Identity
- Trade Name
- GoldenDent FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- Coated Polyglycolic Acid (PGA) Braided Absorbable Suture Violet, 4-0, 19mm, 3/8 reverse cutting needle, Qty 12 FDA UDI
- Model / Reference
- SPGA4 FDA UDI
- Description
- Coated Polyglycolic Acid (PGA) Braided Absorbable Suture Violet, 4-0, 19mm, 3/8 reverse cutting needle, Qty 12 FDA UDI
Identifiers
- Catalog Number
- SPGA4 FDA UDI
- Primary DI / UDI-DI
- 00850028211472 FDA UDI
- 510(k) Number
- K073614 FDA UDI
- FDA Product Code
- GAM FDA UDI
- GMDN Term
- Suturing unit, single-use 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Suturing unit, single-use
GoldenDent by GoldenDent — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Suturing unit, single-use.
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Cleared under the same submission
K073614 also covers:
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PGA Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PGA Sutures — APPLIED DENTAL, INC.
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
- WEGO-PDO Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc.
- WEGO-PDO Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc.
- WEGO-PDO Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc.
- WEGO-PDO Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc.
- WEGO-PDO Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc.
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 II | Pending data |
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Manufacturer
- Manufacturer
- GoldenDent
Sources (1)
- FDA UDI 267a3d9d-8b4e-4811-8f98-b8c3b30f543e 35 fields · synced May 30, 2026