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LapSac
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref G16495 / J-LS-060401Model G16493/J-LS-050201
Identity
- Trade Name
- LapSac™ EUDAMEDLapSac FDA UDI
- Generic Name
- Tissue extraction bag FDA UDI
- Device Name
- LapSac Surgical Tissue Pouch EUDAMEDLapSacTM Surgical Tissue Pouch (4”x6”) FDA UDI
- Model / Reference
- G16493/J-LS-050201 EUDAMEDG16495 / J-LS-060401 EUDAMEDJ-LS-060401 FDA UDI
- Description
- LapSacTM Surgical Tissue Pouch (4”x6”) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937027891 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD132ZM EUDAMED
- FDA Product Code
- KGY FDA UDI
- EMDN Code
- K01020107 MINIMALLY INVASIVE SURGERY RECOVERY BAGS EUDAMED
- GMDN Term
- Tissue extraction bag FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4100 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tissue extraction bag
LapSac by CooperSurgical, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Tissue extraction bag.
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- PARTNERS LC KIT 006 — APPLIED MEDICAL RESOURCES CORP. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (2)
- FDA UDI 710614ad-d93f-44cb-9673-8cae1c93deaf 33 fields · synced Aug 2, 2026
- EUDAMED 2b7fef26-4282-4c20-bf69-bb506cb24798 61 fields · synced Aug 2, 2026