FDA.reportPublic FDA data

Obturator

Primary DI
00841823107152
Brand
Obturator
Company
AD-TECH MEDICAL INSTRUMENT CORPORATION
Model
OB-17-240X
Catalog number
OB-17-240X
Published
2021-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAOINSTRUMENT, SURGICAL, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841823107152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841823107152008418231071528418231071520841823107152

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00To be stored and used within typical hospital/office room ambient temperature and humidity conditions

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)776-1555sales@adtechmedical.com

Regulatory Flags#

DUNS number
174813410
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841823110848Ad-Tech Macro Depth ElectrodeSR12R-SP05X-0BHSR12R-SP05X-0BH2026-02-23
00841823110855Ad-Tech Macro Depth ElectrodeSR08R-SP05X-0BHSR08R-SP05X-0BH2026-02-23
00841823110862Ad-Tech Macro Depth ElectrodeSR08R-SP21X-0C3SR08R-SP21X-0C32026-02-23
00841823110879Ad-Tech Macro Depth ElectrodeSR08R-SP61X-0C3SR08R-SP61X-0C32026-02-23
00841823110886Ad-Tech Macro Depth ElectrodeSR10R-SP05X-0BHSR10R-SP05X-0BH2026-02-23
00841823110893Ad-Tech Macro Depth ElectrodeSR10R-SP21X-0C3SR10R-SP21X-0C32026-02-23
00841823110909Ad-Tech Macro Depth ElectrodeSR10R-SP61X-0C3SR10R-SP61X-0C32026-02-23
00841823110916Ad-Tech Macro Depth ElectrodeSR12R-SP21X-0C3SR12R-SP21X-0C32026-02-23
00841823110923Ad-Tech Macro Depth ElectrodeSR12R-SP61X-0C3SR12R-SP61X-0C32026-02-23
00841823109996SIGNUM Connection System Cable1L-JBL-2DIN2025-12-09
00841823110008SIGNUM Connection System Cable1L-JBL-4DIN2025-12-09
00841823110015SIGNUM Connection System Cable1L-JBL-6DIN2025-12-09
00841823110039SIGNUM Connection System Cable1L-JBL-8DIN2025-12-09
00841823110053SIGNUM Connection System Cable1L-JBL-10DIN2025-12-09
00841823110060SIGNUM Connection System Cable1L-JBL-12BDIN2025-12-09
00841823110077SIGNUM Connection System Cable1L-JBL-14BDIN2025-12-09
00841823110084SIGNUM Connection System Cable1L-JBL-16DIN2025-12-09
00841823110091SIGNUM Connection System Cable1L-JBL-16BDIN2025-12-09
00841823110107SIGNUM Connection System Cable1L-JBL-20DIN2025-12-09
00841823110114SIGNUM Connection System Cable1L-JBL-24BDIN2025-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089664ELMED INCORPORATEDELMED INCORPORATEDHAO2026-03-17
00810220800010Adler Instrument CompanyAdler, Inc.HAO2026-03-17
00810220800034Adler Instrument CompanyAdler, Inc.HAO2026-03-17
04058749078770NAFehling Instruments GmbH & Co. KGHAO2026-03-05
04058749082357NAFehling Instruments GmbH & Co. KGHAO2026-03-05
04058749123500NAFehling Instruments GmbH & Co. KGHAO2026-03-05
00816589021608Mini-Bolt Accessory KitMONTERIS MEDICAL INCHAO2026-02-23
00810123209835Adler Instrument CompanyAdler, Inc.HAO2026-02-10
04058749068443NAFehling Instruments GmbH & Co. KGHAO2026-01-28
04058749068481NAFehling Instruments GmbH & Co. KGHAO2026-01-28
04058749076110NAFehling Instruments GmbH & Co. KGHAO2026-01-28
04058749076349NAFehling Instruments GmbH & Co. KGHAO2026-01-28
00810123209750Adler Instrument CompanyAdler, Inc.HAO2026-01-02
00810123209767Adler Instrument CompanyAdler, Inc.HAO2026-01-02
00873263009321Visualase Anchor Bolt ToolsFHC, INC.HAO2025-12-12
00873263009345Visualase Anchor Bolt DriverFHC, INC.HAO2025-12-12
00873263009352Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009369Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009376Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009383Visualase Anchor Bolt Driver GuideFHC, INC.HAO2025-12-12
00873263009390Visualase Sterilization & Storage TrayFHC, INC.HAO2025-12-12
00873263009406Visualase Anchor Bolt Removal ToolFHC, INC.HAO2025-12-12
04058749001846NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749002010NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749068467NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749069969NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749069976NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749076059NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749082517NAFehling Instruments GmbH & Co. KGHAO2025-12-08
04058749082562NAFehling Instruments GmbH & Co. KGHAO2025-12-08