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citec
FDA UDIEUDAMEDClass I (US FDA UDI)
by Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.
Identity
- Trade Name
- citec FDA UDI
- Generic Name
- Skin stapler/staple, non-bioabsorbable FDA UDI
- Device Name
- Sterile Disposable Skin Stapler. One stapler with: 35R FDA UDI
- Model / Reference
- SSK-35R FDA UDI
- Description
- Sterile Disposable Skin Stapler. One stapler with: 35R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975238201151 FDA UDI
- FDA Product Code
- QQS FDA UDI
- GMDN Term
- Skin stapler/staple, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4740 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
MR Unsafe FDA UDI
Category: Skin stapler/staple, non-bioabsorbable
citec by Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Skin stapler/staple, non-bioabsorbable.
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- TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Multifire Premium — Covidien LP · Class I
- REFLEX — Conmed Corporation · Class I
- WECK — TELEFLEX INCORPORATED · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
Sources (2)
- FDA UDI c81d51ca-aa79-49aa-b1ea-c120900746ec 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026