FDA.reportPublic FDA data

Neo Medical Retractors

Primary DI
07640177823601
Brand
Neo Medical Retractors
Company
Neo Medical SA
Model
RP-00-80-00
Device description
MIS Posterior retractor kit 80mm
Published
2026-07-10
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
true

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640177823601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640177823601076401778236017640177823601

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, single-useA sterile, hand-operated, self-retaining, one-piece 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 intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
486778843
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
true
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
07640177820907Neo Medical Pedicle screw kitSI-MB-00-002026-07-10
07640177821393Neo Medical Pedicle screw kitSS-BS-00-NS2026-07-10
07640177821409Neo Medical Pedicle screw kitSS-CS-01-NS2026-07-10
07640177821416Neo Medical Pedicle screw kitSS-CS-02-NS2026-07-10
07640177823564Neo Medical RetractorsRP-00-40-002026-07-10
07640177823571Neo Medical RetractorsRP-00-50-002026-07-10
07640177823588Neo Medical RetractorsRP-00-60-002026-07-10
07640177823595Neo Medical RetractorsRP-00-70-002026-07-10
07640177823748Neo Medical RetractorsRP-00-40-BL2026-07-10
07640177823755Neo Medical RetractorsRP-00-50-BL2026-07-10
07640177823762Neo Medical RetractorsRP-00-60-BL2026-07-10
07640177823779Neo Medical RetractorsRP-00-70-BL2026-07-10
07640177823786Neo Medical RetractorsRP-00-80-BL2026-07-10
07640177823793Neo Medical RetractorsRP-00-90-BL2026-07-10
07640177823809Neo Medical RetractorsRP-00-AK-002026-07-10
07640177823816Neo Surgical LightsSL-20-00-FL2026-07-10
07640177823007Neo Medical RetractorsRL-01-20-NS2024-02-06
07640177823021Neo Medical RetractorsRL-01-60-NS2024-02-06
07640177823038Neo Medical RetractorsRL-01-80-NS2024-02-06
07640177823045Neo Medical RetractorsRL-00-AK-NS2024-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091872ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-10
00810158211193PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00810158219861PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00888937033687ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033694ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033700ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033717ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033724ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033731ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033748ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033755ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033762ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033779ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033786ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10
00888937033793ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10
00888937033809ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10
00888937033816ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10
07640177823564Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823571Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823588Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823595Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823748Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823755Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823762Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823779Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823786Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823793Neo Medical RetractorsNeo Medical SAGAD2026-07-10
07640177823809Neo Medical RetractorsNeo Medical SAGAD2026-07-10
B382SD9044561000Surgical DirectSurgical Direct, Inc.GAD2026-07-10
00810168190471NAPACIFIC INSTRUMENTS, INC.GAD2026-07-09