Identity
- Trade Name
- Jigsaw Medical,LLC FDA UDI
- Generic Name
- Closed-wound/centesis drainage receptacle FDA UDI
- Device Name
- Sterile Pathway Spike Safety-Vac 1000+ Pre-Vac Wound Drainage Bottle 1000ml With Clave FDA UDI
- Model / Reference
- SV1000-SPWC FDA UDI
- Description
- Sterile Pathway Spike Safety-Vac 1000+ Pre-Vac Wound Drainage Bottle 1000ml With Clave FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856274008620 FDA UDI
- FDA Product Code
- GCY FDA UDI
- GMDN Term
- Closed-wound/centesis drainage receptacle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4680 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Closed-wound/centesis drainage receptacle
Jigsaw Medical, LLC by Jigsaw Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Closed-wound/centesis drainage receptacle.
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- One-Step™ — Merit Medical Systems, Inc. · Class I
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
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
- Jigsaw Medical, Llc
Sources (1)
- FDA UDI 413d5258-ae09-42d4-8648-dd00f78d6acd 33 fields · synced Jun 8, 2026