Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, metal FDA UDI
- Device Name
- NONPERFORATED COMMERCIALLY PURE TITANIUM FOIL 76X100MM .005 THICK FDA UDI
- Model / Reference
- 0039436 FDA UDI
- Description
- NONPERFORATED COMMERCIALLY PURE TITANIUM FOIL 76X100MM .005 THICK FDA UDI
Identifiers
- Catalog Number
- 0039436 FDA UDI
- Primary DI / UDI-DI
- 00614950000234 FDA UDI
- 510(k) Number
- K061397 FDA UDI
- FDA Product Code
- OAT FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, metal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 100 Millimeter FDA UDIWidth — 76 Millimeter FDA UDI
Category: Extra-gynaecological surgical mesh, metal
Ace by Ace Surgical Supply Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Extra-gynaecological surgical mesh, metal.
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- Pyramesh® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Pyramesh® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Pyramesh® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- PYRAMESH® Implant System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
Cleared under the same submission
K061397 also covers:
- ACE — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., INC.
- TRUFIX Bone Fixation System — ACE SURGICAL SUPPLY CO., 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
- Ace Surgical Supply Co., Inc.
Sources (1)
- FDA UDI e5ffa44a-0c93-417a-9eb4-1e27ca188544 37 fields · synced May 31, 2026