Identity
- Trade Name
- Symmetry Secto® FDA UDI
- Generic Name
- Dissection sponge FDA UDI
- Device Name
- Secto® Dissector, One-Piece Gauze, 10 mm, 380 mm, Single-Use, (10/bx) FDA UDI
- Model / Reference
- TDSG10 FDA UDI
- Description
- Secto® Dissector, One-Piece Gauze, 10 mm, 380 mm, Single-Use, (10/bx) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10887482155322 FDA UDI
- 510(k) Number
- K982428 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Dissection sponge FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1720 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 380 Millimeter FDA UDIWidth — 10 Millimeter FDA UDI
Category: Dissection sponge
Symmetry Secto® by Symmetry Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dissection sponge.
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- A Plus — A PLUS INTERNATIONAL, INC · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- FABCO — FIRST AID BANDAGE CO INC · Class I
Cleared under the same submission
K982428 also covers:
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
- Symmetry Surgical Inc.
Sources (1)
- FDA UDI 5b8552c5-274b-40d9-8813-154734e6486e 36 fields · synced May 30, 2026