FDA.reportPublic FDA data

RAVINE® Lateral Access System

Primary DI
10888857035478
Brand
RAVINE® Lateral Access System
Company
VB Spine LLC
Model
2701-90064
Catalog number
2701-90064
Device description
Dissector Size 6 mm
Published
2022-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10888857035478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885703547810888857035478

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(571)919-2000mark.zellers@stryker.com

Regulatory Flags#

DUNS number
119508156
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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10888857598270Xia® 3 System - Serrato®482614545V482614545V2026-07-24
10888857598287Xia® 3 System - Serrato®482615020V482615020V2026-07-24
10888857598294Xia® 3 System - Serrato®482615025V482615025V2026-07-24
10888857598300Xia® 3 System - Serrato®482615030V482615030V2026-07-24
10888857598317Xia® 3 System - Serrato®482615035V482615035V2026-07-24
10888857598324Xia® 3 System - Serrato®482615040V482615040V2026-07-24
10888857598331Xia® 3 System - Serrato®482615045V482615045V2026-07-24
10888857598348Xia® 3 System - Serrato®482615050V482615050V2026-07-24
10888857598355Xia® 3 System - Serrato®482615525V482615525V2026-07-24
10888857598362Xia® 3 System - Serrato®482615530V482615530V2026-07-24
10888857598379Xia® 3 System - Serrato®482615535V482615535V2026-07-24
10888857598386Xia® 3 System - Serrato®482615540V482615540V2026-07-24
10888857598393Xia® 3 System - Serrato®482615545V482615545V2026-07-24

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Primary DI, Brand, Company table
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00889024715295Persona Extended V/V Guide Assembly (MFS)Zimmer, Inc.LXH2026-10-19
08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
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00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
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00810161901432EARP TRIAL 22x40x14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901449EARP TRIAL 22x40x12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
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00810161901463EARP TRIAL 22x45x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
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00810161901692EARP TRIAL 22x50x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901708EARP TRIAL 22x50x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901715EARP TRIAL 22x50x14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
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00840606197007MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
00840606197014MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
00840606197021MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
00840606197038MERCURYSPINAL ELEMENTS, INC.LXH2026-10-16
05055662922622Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDLXH2026-10-16
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