Identity
- Trade Name
- SURGISTAIN (60 Liter Drum) FDA UDI
- Generic Name
- Instrument anti-oxidation agent FDA UDI
- Device Name
- Enzymatic detergents used to clean medical instruments. FDA UDI
- Model / Reference
- 34572-38 FDA UDI
- Description
- Enzymatic detergents used to clean medical instruments. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810929012301 FDA UDI
- FDA Product Code
- FLG FDA UDI
- GMDN Term
- Instrument anti-oxidation agent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6150 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
Yes
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
No
FDA UDI
Category: Instrument anti-oxidation agent
Surgistain (60 Liter Drum) is a medical device used as an enzymatic detergents to clean medical instruments, specifically stainless steel surgical instruments. It prevents corrosion and promotes longevity through its anti-oxidation properties.
Similar devices
Also classified as Instrument anti-oxidation agent.
- SURGISTAIN (55 Gallon/220 Liter Drum) — Ruhof Corporation · Class I
- SURGISTAIN (2 Liter RB38) — Ruhof Corporation · Class I
- SURGISTAIN (4 Liter FB63) — Ruhof Corporation · Class I
- SURGISTAIN (1 Liter bottle) — Ruhof Corporation · Class I
- SURGISTAIN PLUS (4 Liter RB53) — Ruhof Corporation · Class I
- SURGISTAIN (4.2oz/125ml bottle) — Ruhof Corporation · Class I
- SURGISTAIN (5 Liter FB38) — Ruhof Corporation · Class I
- SURGISTAIN (15 Gallon Drum) — Ruhof Corporation · 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
- Ruhof Corporation
Sources (1)
- FDA UDI 23427b8a-fc24-4cec-9b9c-56a529100be0 33 fields · synced Jun 23, 2026