Identity
- Trade Name
- Disposable Transbronchial Needle FDA UDI
- Generic Name
- General-purpose endoscopic needle, single-use FDA UDI
- Device Name
- Sure-Stop Transbronchial Aspiration Needle 21GA Needle Diameter x 1.8mm Sheath Diameter x 13mm Needle Length x 150cm Working Length FDA UDI
- Model / Reference
- 2102 FDA UDI
- Description
- Sure-Stop Transbronchial Aspiration Needle 21GA Needle Diameter x 1.8mm Sheath Diameter x 13mm Needle Length x 150cm Working Length FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813353010288 FDA UDI
- 510(k) Number
- K901438 FDA UDI
- FDA Product Code
- GAA FDA UDI
- GMDN Term
- General-purpose endoscopic needle, single-use 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose endoscopic needle, single-use
Disposable Transbronchial Needle by TeleMed Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose endoscopic needle, single-use.
- Single Use Aspiration Needle NA-U201H — Olympus Medical Systems Corporation · Class II
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
- Porges Coloplast — Coloplast A/S · Class II
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
- Injectra, ScleroTip — Medi-Globe Corporation · Class II
- Single Use Injector NM600/610 — Olympus Medical Systems Corporation · Class II
- Single Use Aspiration Needle NA-U401SX — Olympus Medical Systems Corporation · Class II
- Henry Schein — HENRY SCHEIN, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TeleMed Systems
Sources (1)
- FDA UDI e525f923-e48b-4e1c-9ded-afb4b35f8650 34 fields · synced May 31, 2026