FDA.reportPublic FDA data

SURJEX

Primary DI
G383S1094112202
Brand
SURJEX
Company
SURJEX
Model
11-220
Catalog number
11-220
Device description
Pediatric Deaver Retractor 7/8"X8"
Published
2026-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
G383S1094112202PrimaryHIBCC0

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
645518882
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G383S1084816TC95SURJEX8-16TC8-16TC2026-10-31
G383S1084WM853543327SURJEXWM8535433WM85354332026-10-31
G383S1084WM85354372SURJEXWM8535437WM85354372026-10-31
G383S1084WM98733224SURJEXWM9873322WM98733222026-10-31
G383S1084WM98733234SURJEXWM9873323WM98733232026-10-31
G383S1084WM9873329SURJEXWM9873329WM98733292026-10-31
G383S1085WM3357218SURJEXWM3357218WM33572182026-10-31
G383S1085WM7786614SURJEXWM7786614WM77866142026-10-31
G383S1085WM77866155SURJEXWM7786615WM77866152026-10-31
G383S1090WM9673433SURJEXWM9673433WM96734332026-10-31
G383S1091WM96734332SURJEXWM9673433WM96734332026-10-31
G383S1092WM0202S3SURJEXWM0202S3WM0202S32026-10-31
G383S1092WM0205S3SURJEXWM0205S3WM0205S32026-10-31
G383S1092WM0220S3SURJEXWM0220S3WM0220S32026-10-31
G383S1092WM0405S3SURJEXWM0405S3WM0405S32026-10-31
G383S1092WM0413S3SURJEXWM0413S3WM0413S32026-10-31
G383S1092WM0418S3M4SURJEXWM0418S3WM0418S32026-10-31
G383S1092WM0914S3N7SURJEXWM0914S3WM0914S32026-10-31
G383S1092WM0948S3SURJEXWM0948S3WM0948S32026-10-31
G383S1092WM0958S3SURJEXWM0958S3WM0958S32026-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776437398MillenniumAvalign Technologies, Inc.GAD2026-11-02
00190776437442MillenniumAvalign Technologies, Inc.GAD2026-11-02
G383S1084WM853543327SURJEXSURJEXGAD2026-10-31
G383S1084WM98733224SURJEXSURJEXGAD2026-10-31
G383S1084WM98733234SURJEXSURJEXGAD2026-10-31
G383S1084WM9873329SURJEXSURJEXGAD2026-10-31
G383S10937044323SURJEXSURJEXGAD2026-10-31
G383S10937044343SURJEXSURJEXGAD2026-10-31
G383S10937044353SURJEXSURJEXGAD2026-10-31
G383S1093WM96712533SURJEXSURJEXGAD2026-10-31
G383S1093WM9671255SURJEXSURJEXGAD2026-10-31
G383S1094112182SURJEXSURJEXGAD2026-10-31
G383S1094112192SURJEXSURJEXGAD2026-10-31
G383S1094WM1867025SURJEXSURJEXGAD2026-10-31
G383S1094WM1867125SURJEXSURJEXGAD2026-10-31
G383S1094WM88672125SURJEXSURJEXGAD2026-10-31
G383S10981124048SURJEXSURJEXGAD2026-10-31
G383S1098112424SURJEXSURJEXGAD2026-10-31
G383S1098112444SURJEXSURJEXGAD2026-10-31
00190776437275MillenniumAvalign Technologies, Inc.GAD2026-10-30
00190776437282MillenniumAvalign Technologies, Inc.GAD2026-10-30
00840329838744BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GAD2026-10-30
B382SD914178350Surgical DirectSurgical Direct, Inc.GAD2026-10-30
00190776439811MilleniumAvalign Technologies, Inc.GAD2026-10-28
B382SD907310080Surgical DirectSurgical Direct, Inc.GAD2026-10-28
B382SD9141781200Surgical DirectSurgical Direct, Inc.GAD2026-10-28
B382SD91417912190Surgical DirectSurgical Direct, Inc.GAD2026-10-28
B8039018650ORTHOMEDORTHO-MED, INC.GAD2026-10-27
00190776437145MillenniumAvalign Technologies, Inc.GAD2026-10-26
00190776437152MillenniumAvalign Technologies, Inc.GAD2026-10-26