Identity
- Trade Name
- Exact Medical Manufacturing, Inc. FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- HaloGuard AAMI 4 Surgical Gown, XL, sterile, 1 towel FDA UDI
- Model / Reference
- E10416A0 FDA UDI
- Description
- HaloGuard AAMI 4 Surgical Gown, XL, sterile, 1 towel FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816953020305 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Exact Medical Manufacturing, Inc. by Exact Medical Manufacturing — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Exact Medical Manufacturing
Sources (1)
- FDA UDI 9d147256-5af2-401d-b5aa-7259da7229fc 35 fields · synced Jun 7, 2026