Identity
- Trade Name
- House Brand Dentistry FDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- SMS Gown sewing, SMS 40gsm, Blue, with ties on back collar/waist, knitted cuff, non sterile - 1/pack FDA UDI
- Model / Reference
- HSB-109105 FDA UDI
- Description
- SMS Gown sewing, SMS 40gsm, Blue, with ties on back collar/waist, knitted cuff, non sterile - 1/pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810132800696 FDA UDI
- FDA Product Code
- LYU FDA UDI
- GMDN Term
- Isolation gown, single-use FDA UDI
Classification
- Device Class
- Class I 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Isolation gown, single-use
House Brand Dentistry by Frontier Dental Supply Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Isolation gown, single-use.
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- CONVERTORS — Cardinal Health 200, LLC · Class I
- Industrial Gown - White — ULINE, INC. · Class I
- Protexter — ICP MEDICAL, LLC · Class I
- 3D DENTAL-ESSENTIALS — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- VIVIT Supply — Vivit Supply LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
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
- Frontier Dental Supply Inc
Sources (1)
- FDA UDI 7b677542-acae-4156-bb58-851dd04bd35c 33 fields · synced May 30, 2026