Identity
- Trade Name
- Excella II® FDA UDI
- Generic Name
- Hand-held surgical retractor, reusable FDA UDI
- Device Name
- Silicone, SST FDA UDI
- Model / Reference
- LS-196 FDA UDI
- Description
- Silicone, SST FDA UDI
Identifiers
- Catalog Number
- LS-196 FDA UDI
- Primary DI / UDI-DI
- M711LS1960 FDA UDI
- FDA Product Code
- GDI FDA UDI
- GMDN Term
- Hand-held surgical retractor, reusable 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
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Hand-held surgical retractor, reusable
Excella II® by Innovasis, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held surgical retractor, reusable.
- ATLAS — ATLAS CERRAHİ ALETLER LTD. ŞTİ. · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- Gimmi — Gimmi GmbH · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Sklar® — Sklar Corporation · Class I
- BIOCOMPOSITE PLUS ANCHOR Ø3, 5 MM W/NEEDLE — BMT BAPS BİYO MALZEME SANAYİ VE TİCARET ANONİM ŞİRKETİ · Class III
- Spreizer / Spreader — REDA Instrumente GmbH · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Innovasis, Inc.
Sources (1)
- FDA UDI 7f088e9f-7c00-4950-acd5-82f833ba6be7 35 fields · synced Jun 8, 2026