Identity
- Trade Name
- Premium UNIFY PDO Sutures FDA UDI
- Generic Name
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
- Device Name
- Premium PDO Suture, Size 2-0, 24mm 3/8 Cir Rev Cut, Violet, 27" FDA UDI
- Model / Reference
- PLD-227R24 FDA UDI
- Description
- Premium PDO Suture, Size 2-0, 24mm 3/8 Cir Rev Cut, Violet, 27" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814639025965 FDA UDI
- FDA Product Code
- NEW FDA UDI
- GMDN Term
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4840 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Premium UNIFY PDO Sutures by Applied Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K022666 also covers:
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
K073614 also covers:
- 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.
- WEGO-PDO Absorbable Surgical Suture With Needle — Foosin Medical Supplies, Inc.
K173779 also covers:
- Premium UNIFY Nylon Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PDO Sutures — APPLIED DENTAL, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Applied Dental, Inc.
Sources (1)
- FDA UDI 13571e7a-43ee-4187-af7f-e3601062c226 35 fields · synced May 30, 2026