Identity
- Trade Name
- HaloShield FDA UDI
- Generic Name
- Wound shield FDA UDI
- Device Name
- HaloShield Nipple Protector FDA UDI
- Model / Reference
- G46289 FDA UDI
- Description
- HaloShield Nipple Protector FDA UDI
Identifiers
- Catalog Number
- C-SHIELD-1.0 FDA UDI
- Primary DI / UDI-DI
- 00827002462892 FDA UDI
- 510(k) Number
- K905766 FDA UDI
- FDA Product Code
- GBX FDA UDI
- GMDN Term
- Wound shield FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
Category: Wound shield
HaloShield by Cook Biotech Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound shield.
- Dong-A Pharmaceutical Co., Ltd. — Dong-A Pharmaceutical Co., Ltd. · Class I
- HaloShield — COOK BIOTECH INCORPORATED · Class I
Cleared under the same submission
K905766 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 I | Pending data |
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Manufacturer
- Manufacturer
- Cook Biotech Incorporated
Sources (1)
- FDA UDI 373f8ad4-9fd2-4cf9-b9f7-93b5d11bd8e2 37 fields · synced Jun 1, 2026