Identity
- Trade Name
- Dressing Change Tray, Sterile FDA UDI
- Generic Name
- General surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Dressing Change Tray, Sterile: Instructions, Face Mask, Pair Vinyl Gloves with Wallet, Polylined Drape 13"x18", Tape Measure- 36", Pkg Alcohol Swabsticks (3/pkg), Pkg PVP Swabsticks (3/pkg), Non-woven Split Sponge 4"x4", Non-Adherent Sponge 2"x2", Gauze Sponge 4"x4", Roll Transparent Dressing Tape 3/4"x18", Transparent Dressing 4"x4 3/4", Dressing Change Label, Tray FDA UDI
- Model / Reference
- 4705 FDA UDI
- Description
- Dressing Change Tray, Sterile: Instructions, Face Mask, Pair Vinyl Gloves with Wallet, Polylined Drape 13"x18", Tape Measure- 36", Pkg Alcohol Swabsticks (3/pkg), Pkg PVP Swabsticks (3/pkg), Non-woven Split Sponge 4"x4", Non-Adherent Sponge 2"x2", Gauze Sponge 4"x4", Roll Transparent Dressing Tape 3/4"x18", Transparent Dressing 4"x4 3/4", Dressing Change Label, Tray FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784470528 FDA UDI
- FDA Product Code
- KDD FDA UDI
- GMDN Term
- General surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General surgical procedure kit, non-medicated, single-use
Dressing Change Tray, Sterile by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Dynarex Corp.
Sources (1)
- FDA UDI 98a78ab1-db58-46c0-b517-3442f7d51064 33 fields · synced May 30, 2026