Identity
- Trade Name
- Purstring FDA UDI
- Generic Name
- Suture retention device FDA UDI
- Device Name
- Purse String Device FDA UDI
- Model / Reference
- 020242 FDA UDI
- Description
- Purse String Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521051430 FDA UDI
- 510(k) Number
- K901107 FDA UDI
- FDA Product Code
- GDJ FDA UDI
- GMDN Term
- Suture retention device 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 65 Millimeter FDA UDI
Category: Suture retention device
Purstring by Covidien LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suture retention device.
- FlowStasis Single-Pack — Inari Medical, Inc. · Class I
- Bioseal Inc. — BIOSEAL · Class I
- ATLAS Suture Delivery System — Applied Medical Technology, Inc. · Class II
- Bioseal Inc. — BIOSEAL · Class I
- ETHICON — Ethicon Inc. · Class II
- Bioseal Inc. — BIOSEAL · Class I
- ETHICON — Ethicon Inc. · Class II
- Bioseal Inc. — BIOSEAL · Class I
Cleared under the same submission
K901107 also covers:
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
- Covidien LP
Sources (1)
- FDA UDI 13322d59-7fc4-4d8c-a016-8357191c7b7e 36 fields · synced May 29, 2026