Identity
- Trade Name
- Binocular loupe, 2,5 x magnification FDA UDI
- Generic Name
- Surgical binoculars, reusable FDA UDI
- Device Name
- working distance 340 mm, in case and glasses, incl. holding band & cleaning FDA UDI
- Model / Reference
- 10-140-00 FDA UDI
- Description
- working distance 340 mm, in case and glasses, incl. holding band & cleaning FDA UDI
Identifiers
- Catalog Number
- 10-140-00 FDA UDI
- Primary DI / UDI-DI
- 04053755118922 FDA UDI
- FDA Product Code
- HJH FDA UDI
- GMDN Term
- Surgical binoculars, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.5120 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
Category: Surgical binoculars, reusable
Binocular loupe, 2, 5 x magnification by Spiggle & Theis Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical binoculars, reusable.
- Brilliance — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class I
- Enova Illumination — ENOVA ILLUMINATION, INC · Class I
- SurgiTel — Surgitel · Class I
- Surgical Telescope — Xenosys Co., Ltd. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- SuperVu XL Advantage 3.5x, at 34cm working distanc — Rudolf Riester GmbH & Co. KG · Class I
- Surgical Telescope — Xenosys Co., Ltd. · 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
- Spiggle & Theis Medizintechnik GmbH
Sources (1)
- FDA UDI 11355eba-9262-4e73-906e-9089b970d895 35 fields · synced May 30, 2026