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Infiniti Plus™ Needle Guide
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 610-1232Ref 610-1236Ref 610-1235Ref 610-1214
Identity
- Trade Name
- Infiniti Plus™ Needle Guide EUDAMEDFDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- General Purpose Guidance – In-Plane, Open Channel (Infiniti plus guide) EUDAMEDSterile needle guide with (14 x 91.5cm) telescopically-folded CIV-Flex™ cover FDA UDISterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover FDA UDISterile needle guide with (14 x 29.2cm) telescopically-folded CIV-Flex™ wireless transducer cover FDA UDI
- Model / Reference
- 610-1232 EUDAMEDFDA UDI610-1236 EUDAMED610-1235 EUDAMED610-1214 EUDAMED610-1235, 610-1235-5 FDA UDI610-1236, 610-1236-5 FDA UDI610-1214, 610-1214-5 FDA UDI
- Description
- Sterile needle guide with (14 x 91.5cm) telescopically-folded CIV-Flex™ cover FDA UDISterile needle guide with (14 x 147cm) telescopically-folded CIV-Flex™ cover FDA UDISterile needle guide with (14 x 29.2cm) telescopically-folded CIV-Flex™ wireless transducer cover FDA UDI
Identifiers
- Catalog Number
- 610-1235, 610-1235-5 FDA UDI610-1232 FDA UDI610-1236, 610-1236-5 FDA UDI610-1214, 610-1214-5 FDA UDI
- Primary DI / UDI-DI
- 10841436102725 EUDAMEDFDA UDI10841436102695 EUDAMEDFDA UDI10841436102732 EUDAMEDFDA UDI10841436102473 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD101C1ND EUDAMED
- 510(k) Number
- K093713 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Width — 3 Inch FDA UDILength — 4 Inch FDA UDIWidth — 2.8 Inch FDA UDILength — 3.6 Inch FDA UDI
Category: Needle guide, single-use
Infiniti Plus™ Needle Guide by Civco Medical Instruments Co., Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Needle guide, single-use.
- Sterile Disposable Endocavity Needle Guide Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Sterile transrectal needle guide with sheath — Exact Imaging · Class II
- Sterile Disposable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
- Gangi-SoftGuard Coaxial Needle — Apriomed AB · Class II
- TRUGUIDE — Bard Peripheral Vascular · Class II
Cleared under the same submission
K093713 also covers:
- AccuSITE Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- AccuSITE™ Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Brackt — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.
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
- Civco Medical Instruments Co., Inc.
Sources (8)
- FDA UDI 40a9aa9c-8a4d-4da4-a75b-2e8f54d41f67 38 fields · synced Aug 3, 2026
- FDA UDI c7c34660-235c-4b85-98e9-4f6fe1dd96b9 38 fields · synced May 25, 2026
- FDA UDI 1d0c2d6a-a2e3-43c7-9e61-c0966858c41d 38 fields · synced May 25, 2026
- FDA UDI 3ef68824-bcdc-4b2b-8696-60f6fb9d1b95 38 fields · synced May 30, 2026
- EUDAMED 6f30c41e-2a14-4427-8e5a-1a29ab4017a9 61 fields · synced Jul 9, 2026
- EUDAMED 7979ca38-52eb-4562-a72b-ab72a24e3a91 61 fields · synced Jul 11, 2026
- EUDAMED 1608cea0-3c9c-4f05-88b2-59cb19169034 61 fields · synced Jul 20, 2026
- EUDAMED 732c418b-4fa9-47c5-8fee-9ba2f1218c61 61 fields · synced Aug 3, 2026