Identity
- Trade Name
- ACE FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, metal FDA UDI
- Device Name
- TI MICRO MESH 98.5 X 77.5MM 0.25MM THICK CP TI GRADE 1 NON-STERILE FDA UDI
- Model / Reference
- 00394701 FDA UDI
- Description
- TI MICRO MESH 98.5 X 77.5MM 0.25MM THICK CP TI GRADE 1 NON-STERILE FDA UDI
Identifiers
- Catalog Number
- 00394701 FDA UDI
- Primary DI / UDI-DI
- 00614950031436 FDA UDI
- 510(k) Number
- K080074 FDA UDI
- FDA Product Code
- DZE 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
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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Cleared under the same submission
K080074 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 9b5faffb-f925-4ed7-b407-61a435fee935 36 fields · synced May 30, 2026