Identity
- Trade Name
- J-Pass Suture Passer FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- Suture passer used for passing suture around boney structures. FDA UDI
- Model / Reference
- FG1001 FDA UDI
- Description
- Suture passer used for passing suture around boney structures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860366001406 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Suturing unit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
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
No
FDA UDI
Category: Suturing unit, single-use
J-Pass Suture Passer by Coracoid Solutions, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suturing unit, single-use.
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- Arthrex® — Arthrex, Inc. · Class I
- OverStitch NXT Endoscopic Suturing System — Apollo Endosurgery · Class II
- SlingShot — Stryker Corp. · Class I
- NanoPass — Stryker Corp. · Class I
- DISPOSABLE NITINOL NDL SINGLE PACK — Biomet Orthopedics, Inc. · 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
- Coracoid Solutions, Inc.
Sources (1)
- FDA UDI b4abbe95-65bf-4404-b3f1-cfd663ae831b 33 fields · synced Jun 1, 2026