FDA.reportPublic FDA data

Nerve Root Suction-Retractor

Primary DI
M906NRRSCTN0
Brand
Nerve Root Suction-Retractor
Company
INTRINSIC THERAPEUTICS, INC.
Model
400904
Catalog number
NRR-SCTN
Device description
Hand-held reusable surgical retractor for use in spinal surgery with a built-in connector to accept a suction hose.
Published
2021-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M906NRRSCTN0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
781.932.0222quality@barricaid.com

Regulatory Flags#

DUNS number
105722131
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M906BARMALLETA0Surgical Mallet (Slotted)400932BAR-MALLET-A2026-09-04
M906BARMALLET0Surgical Mallet (Slotted)400929BAR-MALLET2020-02-04
M906KITD7NARROW0Barricaid® Narrow Anchor ACD - Reusable Instruments Kit4001009KIT-D7-NARROW2026-01-15
M906AT10NARROW0Barricaid® Narrow Anchor ACD Alignment Trial (10mm)400944AT-10-NARROW2026-01-15
M906AT8NARROW0Barricaid® Narrow Anchor ACD Alignment Trial (8mm)400943AT-8-NARROW2026-01-15
M906BARA610MM0Barricaid® Narrow Anchor ACD (Annular Closure Device)2741015-A6BAR-A6-10MM2026-01-15
M906BARA68MM0Barricaid® Narrow Anchor ACD (Annular Closure Device)2740815-A6BAR-A6-8MM2026-01-15
M906BARIMPACTOR0Barricaid® ACD Impactor400906-ABAR-IMPACTOR2020-02-04
M906WED1A0Barricaid ACD Retraction Wedge400846WED-1-A2019-05-14
M906KITD70Barricaid® ACD - Reusable Instruments Kit4001007KIT-D72021-02-15
M906BARAT100Barricaid® ACD Alignment Trial (10mm)400877BAR-AT-102020-02-04
M906BARAT80Barricaid® ACD Alignment Trial (8mm)400879BAR-AT-82020-02-04
M906BARDMT10X110Defect Measurement Tool (10/11mm)400212BAR-DMT-10X112020-02-04
M906BARDMT12X130Defect Measurement Tool (12/13mm)400213BAR-DMT-12X132020-02-04
M906BARDMT4X50Defect Measurement Tool (4/5mm)400209BAR-DMT-4X52020-02-04
M906BARDMT6X70Defect Measurement Tool (6/7mm)400210BAR-DMT-6X72020-02-04
M906BARDMT8X90Defect Measurement Tool (8/9mm)400211BAR-DMT-8X92020-02-04
M906BARWEDGE0Barricaid® ACD Retraction Wedge400846BAR-WEDGE2020-02-04
M906KITD4C10Barricaid® ACD - Reusable Instruments Kit (Tray Only)400885KIT-D4-C12020-02-04
M906KITD40Barricaid® ACD - Reusable Instruments Kit4001004KIT-D42019-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
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00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03