Identity
- Trade Name
- Injection needle FDA UDI
- Generic Name
- Tissue injection cannula FDA UDI
- Device Name
- bayonet, Luer-Lock 0.8 mm, wl 8.5 cm, total length 13 cm FDA UDI
- Model / Reference
- 40-553-02 FDA UDI
- Description
- bayonet, Luer-Lock 0.8 mm, wl 8.5 cm, total length 13 cm FDA UDI
Identifiers
- Catalog Number
- 40-553-02 FDA UDI
- Primary DI / UDI-DI
- 04250676733696 FDA UDI
- FDA Product Code
- GDM FDA UDI
- GMDN Term
- Tissue injection cannula 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
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Tissue injection cannula
Injection needle by Spiggle & Theis Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tissue injection cannula.
- STERiGLIDE TM — TSK LABORATORY, JAPAN · Class I
- PD NANO CANNULA — YONG CHANG Corporation · Class I
- CSH CANNULA — TSK LABORATORY, JAPAN · Class I
- DISPOSABLE TUMESCENT INFILTRATION CANNULA — AESTHETIC GROUP · Class I
- STERiGLIDE TM — TSK LABORATORY, JAPAN · Class I
- DISPOSABLE MICRO CANNULA FOR FILLER INJECTION KIT — AESTHETIC GROUP · Class I
- STERiGLIDE TM — TSK LABORATORY, JAPAN · Class I
- DISPOSABLE FAT INJECTION CANNULA — AESTHETIC GROUP · 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
- Spiggle & Theis Medizintechnik GmbH
Sources (1)
- FDA UDI d134bdce-52c2-40a7-b53f-33994f7f2e2b 35 fields · synced Jun 8, 2026