FDA.reportPublic FDA data

Neo Medical Retractors

Primary DI
07640177823021
Brand
Neo Medical Retractors
Company
Neo Medical SA
Model
RL-01-60-NS
Device description
Lateral retractor kit 160mm
Published
2024-02-06
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
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
07640177823021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640177823021076401778230217640177823021

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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

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
07640177823601Neo Medical RetractorsRP-00-80-002026-07-10
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
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
00190776417116MillenniumAvalign Technologies, Inc.GAD2026-08-19
00190776417123MillenniumAvalign Technologies, Inc.GAD2026-08-19
00190776426613MillenniumAvalign Technologies, Inc.GAD2026-08-19
00190776426620MillenniumAvalign Technologies, Inc.GAD2026-08-19
00190776417017MillenniumAvalign Technologies, Inc.GAD2026-08-18
00190776417024MillenniumAvalign Technologies, Inc.GAD2026-08-18
00190776417031MillenniumAvalign Technologies, Inc.GAD2026-08-18
00190776425876MillenniumAvalign Technologies, Inc.GAD2026-08-18
00190776426453MillenniumAvalign Technologies, Inc.GAD2026-08-18
00198506093876ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506093883ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506093890ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506093906ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506093913ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506093920ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506093968ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506093999ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506094019ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506094026ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506094033ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506094040ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506094125ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00198506094132ELMED INCORPORATEDELMED INCORPORATEDGAD2026-08-18
00810130207459MSIModern Surgical Instruments LLCGAD2026-08-18
00810130207466MSIModern Surgical Instruments LLCGAD2026-08-18
00810130207473MSIModern Surgical Instruments LLCGAD2026-08-18
00810130207480MSIModern Surgical Instruments LLCGAD2026-08-18
00810130207497MSIModern Surgical Instruments LLCGAD2026-08-18
00810130207503MSIModern Surgical Instruments LLCGAD2026-08-18
00810130207510MSIModern Surgical Instruments LLCGAD2026-08-18