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Herniatome
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 5091709Ref 5091445 CRef 5091445 CRRef 5091745Ref 5091843 RRef 5091945 CRRef 5091849 RRef 5091745 CRRef 5091849 BRRef 5091845Ref 5091843Ref 5091849 BRef 5091845 CRRef 5091809Ref 5091735Ref 5091409Ref 5091949Ref 5091759 RRef 5091749 BRef 5091845 RRef 5091449 CRRef 5091949 CRef 5091849 CRRef 5091755Ref 5091945 CRef 5091845 CRef 5091949 CRRef 5091849Ref 5091415Ref 5091745 RRef 5091749 RRef 5091749 BR
by Adria Srl
Identity
- Trade Name
- HERNIATOME EUDAMEDFDA UDI
- Generic Name
- Diskectomy system, percutaneous, automatic FDA UDI
- Device Name
- Devices for percutaneous discectomy and motorized for vertebroplasty / kyphoplasty EUDAMEDPercutaneous Discectomy Device FDA UDI
- Model / Reference
- 5091745 EUDAMEDFDA UDI5091709 EUDAMED5091445 C EUDAMED5091445 CR EUDAMED5091843 R EUDAMED5091945 CR EUDAMED5091849 R EUDAMED5091745 CR EUDAMED5091849 BR EUDAMED5091845 EUDAMED5091843 EUDAMED5091849 B EUDAMED5091845 CR EUDAMED5091809 EUDAMED5091735 EUDAMED5091409 EUDAMED5091949 EUDAMED5091759 R EUDAMED5091749 B EUDAMED5091845 R EUDAMED5091449 CR EUDAMED5091949 C EUDAMED5091849 CR EUDAMED5091755 EUDAMED5091945 C EUDAMED5091845 C EUDAMED5091949 CR EUDAMED5091849 EUDAMED5091415 EUDAMED5091745 R EUDAMED5091749 R EUDAMED5091749 BR EUDAMED
- Description
- Percutaneous Discectomy Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08053175000070 EUDAMED08053175000056 EUDAMED08053175000063 EUDAMED08053175000100 EUDAMED08053175000377 EUDAMED08053175000513 EUDAMED08053175000391 EUDAMED08053175000445 EUDAMED08053175000490 EUDAMED08053175000216 EUDAMED08053175000117 EUDAMED08053175000285 EUDAMED08053175000483 EUDAMED08053175000193 EUDAMED08053175000094 EUDAMED08053175000001 EUDAMED08053175000148 EUDAMED08053175000360 EUDAMED08053175000247 EUDAMED08053175000384 EUDAMED08053175000421 EUDAMED08053175000315 EUDAMED08053175000506 EUDAMED08053175000155 EUDAMED08053175000308 EUDAMED08053175000278 EUDAMED08053175000520 EUDAMED08053175000230 EUDAMED08053175000018 EUDAMED08053175000339 EUDAMED08053175000346 EUDAMED08053175000452 EUDAMED08033737113844 FDA UDI
- Basic UDI-DI
- 803373711K0299VX EUDAMED
- 510(k) Number
- K141557 FDA UDI
- FDA Product Code
- HRX FDA UDI
- EMDN Code
- A01020102 ASPIRATION FINE NEEDLES AND KITS EUDAMED
- GMDN Term
- Diskectomy system, percutaneous, automatic FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Diskectomy system, percutaneous, automatic
Herniatome by Adria Srl — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Diskectomy system, percutaneous, automatic.
- Biopsy Needle — Argon Medical Devices, Inc. · Class IIa
- INTRODUTTORE — BIOPSYBELL SRL · Class IIa
- CHIBELL CON SIRINGA — BIOPSYBELL SRL · Class IIa
- CHIBELL — BIOPSYBELL SRL · Class IIa
- Biopsy Needle — Argon Medical Devices, Inc. · Class IIa
- 0ME2320 — Biomedical S.r.l. · Class IIa
- 0ME1810 — Biomedical S.r.l. · Class IIa
- DISKIT — BIOPSYBELL SRL · Class IIa
Cleared under the same submission
K141557 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Adria Srl
Sources (33)
- FDA UDI d27622ba-a936-4dc4-961f-a69894a37564 34 fields · synced Sep 17, 2026
- EUDAMED 1b5f082e-978a-4d67-8d71-b8ef6177e83b 61 fields · synced Jun 20, 2026
- EUDAMED 62332107-ebe5-4b54-80d4-616dfff2cb4c 61 fields · synced Jun 20, 2026
- EUDAMED 1b18486a-0201-4ed3-91f3-c40b8cda1ec3 61 fields · synced Jul 9, 2026
- EUDAMED e2d76385-6146-4d8a-90fa-b7e7b92a7c76 61 fields · synced Jul 9, 2026
- EUDAMED 2f626dd3-4f01-4ce4-9f24-8bbec199723b 61 fields · synced Jul 9, 2026
- EUDAMED 926b0280-8f65-4dbd-891a-eefe7a290c07 61 fields · synced Jul 10, 2026
- EUDAMED ae43a821-a355-4ecb-9f61-584b97844948 61 fields · synced Jul 10, 2026
- EUDAMED 1cffc4e6-e2fd-4753-a9b4-9129cbdcdfeb 61 fields · synced Jul 10, 2026
- EUDAMED 71f1a188-5e2c-48cd-b2fb-787883559c9f 61 fields · synced Jul 12, 2026
- EUDAMED d843576d-2061-48f4-8f23-2c95f68bb6a7 61 fields · synced Jul 12, 2026
- EUDAMED 8ef877c2-b509-4441-9b51-2308437645ad 61 fields · synced Jul 12, 2026
- EUDAMED 155a68fb-c8ca-4613-bdda-0b7bc469422f 61 fields · synced Jul 13, 2026
- EUDAMED b13ad230-0a3c-4873-a11a-f3408a5d1efb 61 fields · synced Jul 15, 2026
- EUDAMED 91b63091-d8c3-4f73-8206-e0a446bc55ee 61 fields · synced Jul 16, 2026
- EUDAMED 1972186b-1090-4c24-91d2-e8f7b5ff25ba 61 fields · synced Jul 16, 2026
- EUDAMED d3817840-81d3-4972-9d59-d02bfe0d5c4e 61 fields · synced Jul 16, 2026
- EUDAMED 7e7b8a86-9de7-46bd-bf48-bb6e7d7a393b 61 fields · synced Jul 17, 2026
- EUDAMED f85bc11a-d613-4e03-bd44-2f38f645ef61 61 fields · synced Jul 17, 2026
- EUDAMED a17920b3-2282-498b-9cb7-64bc0c67cbe8 61 fields · synced Jul 19, 2026
- EUDAMED 8555f2a5-f010-443d-9e50-46cc707b877f 61 fields · synced Jul 19, 2026
- EUDAMED a364b413-7d03-4c4b-ae5f-6e285836902d 61 fields · synced Jul 20, 2026
- EUDAMED 069845c8-2518-4624-858a-cd0f951d1aa6 61 fields · synced Jul 22, 2026
- EUDAMED 69b4f803-80ac-44be-8805-708b308e42b5 61 fields · synced Jul 25, 2026
- EUDAMED f431a6c2-bae5-4a1a-bde9-8d43086ec8d1 61 fields · synced Jul 27, 2026
- EUDAMED fa270472-b3e7-4146-aae3-2ee4f908afde 61 fields · synced Jul 28, 2026
- EUDAMED 59db1406-bd3e-452e-a7d4-e1f8e39414ee 61 fields · synced Jul 28, 2026
- EUDAMED 41772c36-6beb-44ef-9d42-dd6edc14212f 61 fields · synced Jul 29, 2026
- EUDAMED f6a4842d-708f-454c-9d45-eb7da03fd8e8 61 fields · synced Jul 29, 2026
- EUDAMED 1eae42ff-bc82-407b-8263-7b27acc8d8d1 61 fields · synced Jul 30, 2026
- EUDAMED 7d38bfe6-93b5-421b-b43c-f6a37c3b91e7 61 fields · synced Aug 4, 2026
- EUDAMED 2ba4e2ff-9fdd-4f94-9fcf-65e51d166da0 61 fields · synced Aug 4, 2026
- EUDAMED 72959185-34df-4e12-8d15-9450dc6f6f75 61 fields · synced Sep 17, 2026