Identity
- Trade Name
- Surgiform FDA UDI
- Generic Name
- Silicone-block tissue reconstructive material FDA UDI
- Device Name
- "SB-1SF Silicone Block - Size One - Soft -Flesh Tone Silicone Implants" FDA UDI
- Model / Reference
- SB-1SF FDA UDI
- Description
- "SB-1SF Silicone Block - Size One - Soft -Flesh Tone Silicone Implants" FDA UDI
Identifiers
- Catalog Number
- SB-1SF FDA UDI
- Primary DI / UDI-DI
- 00851988007839 FDA UDI
- 510(k) Number
- K983755 FDA UDI
- FDA Product Code
- MIB FDA UDI
- GMDN Term
- Silicone-block tissue reconstructive material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Silicone-block tissue reconstructive material
Surgiform by Surgical Technology Laboratories Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silicone-block tissue reconstructive material.
- SG Gluteal Implant — Implantech Associates, Inc. · Class II
- Gluteal Implant — Aart · Class II
- Contoured Carving Block — Implantech Associates, Inc. · Class II
- ContourFlex™ Calf Implant Sizer — Implantech Associates, Inc. · Class II
- Spectrum Designs Medical — Spectrum Designs, Inc. · Class II
- Powerflex™ Pectoral Implant — Implantech Associates, Inc. · Class II
- SG Pec Sizer — Implantech Associates, Inc. · Class II
- SG Pec Implant Style 4 — Implantech Associates, Inc. · Class II
Cleared under the same submission
K983755 also covers:
- SURGIFORM — SURGICAL TECHNOLOGY LABORATORIES INC.
- SURGIFORM — SURGICAL TECHNOLOGY LABORATORIES INC.
- SURGIFORM — SURGICAL TECHNOLOGY LABORATORIES INC.
- SURGIFORM — SURGICAL TECHNOLOGY LABORATORIES INC.
- SURGIFORM — SURGICAL TECHNOLOGY LABORATORIES INC.
- SURGIFORM — SURGICAL TECHNOLOGY LABORATORIES INC.
- SURGIFORM — SURGICAL TECHNOLOGY LABORATORIES INC.
- SURGIFORM — SURGICAL TECHNOLOGY LABORATORIES INC.
- SURGIFORM — SURGICAL TECHNOLOGY LABORATORIES INC.
- SURGIFORM — SURGICAL TECHNOLOGY LABORATORIES INC.
- SURGIFORM — SURGICAL TECHNOLOGY LABORATORIES INC.
- SURGIFORM — SURGICAL TECHNOLOGY LABORATORIES 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
- Surgical Technology Laboratories Inc.
Sources (1)
- FDA UDI c46ac817-9e98-4316-953d-ceeaef050a1b 35 fields · synced May 31, 2026