FDA.reportPublic FDA data

Dura Separator, Baker, Reusable

Primary DI
00810607000613
Brand
Dura Separator, Baker, Reusable
Company
ACRA-CUT INC
Model
800-719
Catalog number
800-719
Device description
Dura Separator, Baker, Reusable Set Consisting Of One Each #0 Cat#800-715 ID#00810607000576,#1 Cat#800-716 ID#00810607000583,#2 Cat#800-717 ID#00810607000590,#3 Cat#800-718 ID#00810607000606
Published
2017-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810607000613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810607000613008106070006138106070006130810607000613

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical probeA non-sterile, slender, rod-like, hand-held manual surgical instrument, typically made of metal, with an angled tip and a handle, designed for exploring/dissecting intracranial structures during a surgical procedure (e.g., tumour removal, third ventriculostomy, cyst fenestration). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9782632210info@acracut.com

Regulatory Flags#

DUNS number
612611459
Device count
1
Premarket exempt
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810607000224Distraction Screws Caspar type800-499800-4992017-05-01
00810607000231Distraction Screws Caspar type800-499x800-499x2017-05-01
00810607000248Distraction Screw Caspar type800-500800-5002017-05-01
00810607000255Distraction Screws Caspar type800-500x800-500x2017-05-01
00810607000262Distraction Screws Caspar type800-501800-5012017-05-01
00810607000279Distraction Screws Caspar type800-501x800-501x2017-05-01
00810607000286Distraction Screws Caspar type800-502800-5022017-05-01
00810607000293Distraction Screws Caspar type800-502x800-502x2017-05-01
00810607002006ACRA-CUT14/9mm SDR (SMARTdrill)200-5002016-09-23
00810607002211ACRA-CUT14/11mm CDM210-2212016-09-23
00810607002310ACRA-CUT11/7mm DG-II mini200-3312016-09-23
00810607002419ACRA-CUT14/11mm DGR-I200-2412016-09-23
00810607002433ACRA-CUT11/7mm DR-I mini200-2432016-09-23
00810607002518ACRA-CUT14/11mm DGR-II200-2512017-01-17
00810607002532ACRA-CUT11/7mm DGR-II Mini200-2532016-09-23
00810607002556ACRA-CUT13/9mm DGR-II200-2552017-01-17
00810607002716ACRA-CUT14/11mm DGR-O200-2712016-09-23
00810607002754ACRA-CUT13/9mm DGR-O200-2752016-09-23
00810607002839ACRA-CUT8/5mm DGR-OS mini Stereotactic200-2832016-09-23
00810607000019Disposable Cranial Perforator200-241 14/11mm200-241 DGR-I2017-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400545MillenniumAvalign Technologies, Inc.HAO2026-07-19
00190776402105MillenniumAvalign Technologies, Inc.HAO2026-07-19
00190776400286MillenniumAvalign Technologies, Inc.HAO2026-07-17
04058749078794NAFehling Instruments GmbH & Co. KGHAO2026-07-17
00190776400231MillenniumAvalign Technologies, Inc.HAO2026-07-16
00190776395445MillenniumAvalign Technologies, Inc.HAO2026-07-14
00190776395735MillenniumAvalign Technologies, Inc.HAO2026-07-14
00190776395742MillenniumAvalign Technologies, Inc.HAO2026-07-14
00190776395759MillenniumAvalign Technologies, Inc.HAO2026-07-14
00190776395391MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395407MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395414MillenniumAvalign Technologies, Inc.HAO2026-07-13
00190776395421MillenniumAvalign Technologies, Inc.HAO2026-07-13
04946329056440CEA Scissors 170 mm, 35 deg. Downward CvdMIZUHO CORPORATIONHAO2026-05-29
04946329056457CEA Scissors 180 mm, Sideward Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329056464CEA Micro Scissors 170 mm, 35 deg. Downward Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329056471CEA Thin Needle Holder 170 mmMIZUHO CORPORATIONHAO2026-05-29
04946329056488CEA Micro Forceps 180 mm, Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329056495CEA Micro Forceps 180 mm, L Str.MIZUHO CORPORATIONHAO2026-05-29
04946329056501CEA Micro Forceps 150 mm, S Str.MIZUHO CORPORATIONHAO2026-05-29
04946329058802Yasargil micro raspatory, curved, 18.5 cmMIZUHO CORPORATIONHAO2026-05-29
04946329058987Micro Scissors 130 mm, FHMIZUHO CORPORATIONHAO2026-05-29
04946329077476Pediatric Mosquito Applier without Hook StrMIZUHO CORPORATIONHAO2026-05-29
04946329077582Bulldog Clamp 82 mm, L Str.MIZUHO CORPORATIONHAO2026-05-29
04946329077599Bulldog Clamp 67 mm, S Str.MIZUHO CORPORATIONHAO2026-05-29
04946329077605Bulldog Clamp 54 mm, L-Shaped.MIZUHO CORPORATIONHAO2026-05-29
04946329077612Bulldog Clamp 67 mm, L Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329077629Bulldog Clamp 57 mm, S Cvd.MIZUHO CORPORATIONHAO2026-05-29
04946329150216Micro Scissors Streamline S, 175 mm Straight, Super Fine TipMIZUHO CORPORATIONHAO2026-05-29
04946329150223Micro Scissors Streamline S, 175 mm Curved, Super Fine TipMIZUHO CORPORATIONHAO2026-05-29