Nexframe Screws

Primary DI
00873263008041
Brand
Nexframe Screws
Company
FHC, INC.
Model
SR-10-00873
Catalog number
SR-10
Device description
1.6 x 10mm Cranial Bone Screws (3)
Published
2025-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K012366000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012366000NAVIGUS II TRAJECTORY GUIDEImage-Guided Neurologics, Inc.2001-10-01HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10873263008734PrimaryGS10
00873263008041Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087326300873410873263008734
00873263008041008732630080418732630080410873263008041

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
Storage Environment Temperature-34 Degrees Celsius57 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)326-2905fhcinc@fh-co.com

Regulatory Flags#

DUNS number
108179458
Device count
3
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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