Identity
- Trade Name
- Blue Sky Bio, LLC. FDA UDI
- Generic Name
- Polyglycolic acid suture FDA UDI
- Model / Reference
- PG40FS2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815131022230 FDA UDI
- 510(k) Number
- K073614 FDA UDI
- FDA Product Code
- GAM FDA UDI
- GMDN Term
- Polyglycolic acid suture 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
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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Polyglycolic acid suture
Blue Sky Bio, LLC. by Blue Sky Bio Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyglycolic acid suture.
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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
- Blue Sky Bio Llc
Sources (1)
- FDA UDI 38364a16-b69d-4189-9a93-590685d0a4df 33 fields · synced Jun 8, 2026