FDA.reportPublic FDA data

NA

Primary DI
06974813832797
Brand
NA
Company
Sinovation (Beijing) Medical Technology Co., Ltd
Model
PRB-CR-S
Device description
Pointer Probe
Published
2026-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220072000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220072000Sinobot X1Sinovation (Beijing) Medical Technology Co., Ltd.2023-06-18HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974813832797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974813832797069748138327976974813832797

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
560671783
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974813832681NAGUD-CR-G2026-09-29
06974813832698NAGUD-DBS-AO2026-09-29
06974813832704NAGUD-DBS-LP2026-09-29
06974813832711NATT-2.2-302026-09-29
06974813832728NATT-2.2-702026-09-29
06974813832735NATT-2.5-702026-09-29
06974813832742NATT-5.0-652026-09-29
06974813832759NATT-50-30D2026-09-29
06974813832766NATT-50-40D2026-09-29
06974813832773NATT-50-50D2026-09-29
06974813832780NATT-50-35D2026-09-29
06974813832810NATT-50-45D2026-09-29
06974813832827NAGD-122026-09-29
06974813832834NASDA-A21-32026-09-29
06974813832841NASDA-A30-12026-09-29
06974813830069NA371000032023-08-31
06974813830076NA371000052023-08-31
06974813830083NA371000132023-08-31
06974813830113NA371000162023-08-31
06974813830199NA371000082023-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974813832681NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832698NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832704NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832711NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832728NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832735NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832742NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832759NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832766NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832773NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832780NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832810NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832827NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832834NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
06974813832841NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
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00199150054442ZEISS PENTERO 800SMEDTRONIC NAVIGATION, INC.HAW2026-09-21
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