Identity
- Trade Name
- Gimmi FDA UDI
- Generic Name
- Rigid endoscope obturator FDA UDI
- Device Name
- Sheaths EUDAMEDURETHROTOME OBTURATOR FOR SHEATH T.9635.00 FDA UDI
- Model / Reference
- T.9635.01 EUDAMEDFDA UDI
- Description
- URETHROTOME OBTURATOR FOR SHEATH T.9635.00 FDA UDI
Identifiers
- Catalog Number
- T.9635.01 FDA UDI
- Primary DI / UDI-DI
- 04049047109105 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049047AAD09BIA27DREVV EUDAMED
- Direct Marketing DI
- 04049047109105 EUDAMED
- FDA Product Code
- EZO FDA UDI
- EMDN Code
- A070599 CAPS OR OBTURATORS - OTHER EUDAMED
- GMDN Term
- Rigid endoscope obturator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4770 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid endoscope obturator
Gimmi by Gimmi GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscope obturator.
- Arthroscopy bridge — SOPRO-COMEG GmbH · Class II
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- TAUT — TELEFLEX INCORPORATED · Class II
- Hysteroscopy obturator — SOPRO-COMEG GmbH · Class II
- Spinal surgery spongiosa pushers — Richard Wolf GmbH · Class I
- USA Elite — Gyrus Acmi, Inc. · Class II
- Trabecular Metal® — Zimmer, Inc. · Class I
- SHARK — Richard Wolf GmbH · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Gimmi GmbH
Sources (2)
- FDA UDI a745d4aa-21a8-4925-b61a-5d379a3ffce6 35 fields · synced Jul 17, 2026
- EUDAMED 9207cb8e-0b30-4134-acc1-a89952ca61e8 61 fields · synced Jul 17, 2026