Identity
- Trade Name
- HALYARD FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- Valueselect*Gown_Reniforcement_Medium_35g SMS_Non-sterile_459ea/cs FDA UDI
- Model / Reference
- 46677-81 FDA UDI
- Description
- Valueselect*Gown_Reniforcement_Medium_35g SMS_Non-sterile_459ea/cs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16931918192024 FDA UDI
- 510(k) Number
- K102652 FDA UDI
- FDA Product Code
- FYA FDA UDI
- GMDN Term
- Surgical gown, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Surgical gown, single-use
A comprehensive 2-3 paragraph SEO description written in clear, natural language.
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Cleared under the same submission
K102652 also covers:
- Alleset — GRI Medical & Electronic Technology Co., Ltd.
- Alleset — GRI Medical & Electronic Technology Co., Ltd.
- Alleset — GRI Medical & Electronic Technology Co., Ltd.
- Alleset — GRI Medical & Electronic Technology Co., Ltd.
- Alleset — GRI Medical & Electronic Technology Co., Ltd.
- Alleset — GRI Medical & Electronic Technology Co., Ltd.
- Alleset — GRI Medical & Electronic Technology Co., Ltd.
- BVI — GRI Medical & Electronic Technology Co., Ltd.
- BVI — GRI Medical & Electronic Technology Co., Ltd.
- Beaver Visitec Inter — GRI Medical & Electronic Technology Co., Ltd.
- HALYARD — GRI Medical & Electronic Technology Co., Ltd.
- HALYARD — GRI Medical & Electronic Technology Co., Ltd.
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
- GRI Medical & Electronic Technology Co., Ltd.
Sources (1)
- FDA UDI 36271909-66f2-41e4-848a-1c5cfb5c9d2e 35 fields · synced Sep 18, 2026