FDA.reportPublic FDA data

DynaTrac Retractor Frames

Primary DI
00842102116513
Brand
DynaTrac Retractor Frames
Company
FLEXBAR MACHINE CORPORATION
Model
41300
Device description
SureStay Holder
Published
2026-10-14
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
00842102116513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842102116513008421021165138421021165130842102116513

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system, reusableA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
047644935
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00842102116506StrongArm Surgical Holders and Positioners73041-XL2026-10-07
00842102116469Flexarm Surgical Holders and Positioners998002026-08-03
00842102116452Deluxe Laparoscopic Instruments91491-D-CF-452026-07-28
00842102105029Mediflex Fiber Optic Lightwand72078720782016-09-17
00842102116445Holders and Positioners - DynaTrac78002-2HP2026-04-08
00842102116438Mini-Bookler Table Mounted Retractor Systems72239-B2026-03-30
00842102116421Bookler Table Mounted Retractor Systems72072-42026-03-19
00842102116391Bookler Table Mounted Retractor Systems757072026-02-09
00842102116407Bookler Table Mounted Retractor Systems69615-102026-02-09
00842102116384StrongArm Surgical Holders and Positioners212812025-11-26
00842102114618Bookler Table Mounted Retractor Systems550122021-08-18
00842102116377Bookler Table Mounted Retractor Systems750662025-09-12
00842102116360Flexarm Surgical Holders and Positioners75-99056-QC-BS012025-08-26
00842102116339Mini-Bookler Table Mounted Retractor Systems551002025-08-18
00842102116346Mini-Bookler Table Mounted Retractor Systems55100-SA2025-08-18
00842102116353Mini-Bookler Table Mounted Retractor Systems550182025-08-18
00842102116322Mediflex Universal Round Bar Table Mounted Retractor Systems75843-R2025-08-06
00842102116315Holders and Positioners - Nathanson Hooks758442025-07-28
00842102116254Mini-Bookler Table Mounted Retractor Systems55013-IL2025-07-11
00842102116261Mini-Bookler Table Mounted Retractor Systems55014-IL2025-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995266936Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
00810130207572MSIModern Surgical Instruments LLCGAD2026-10-15
00810130207589MSIModern Surgical Instruments LLCGAD2026-10-15
00810220800645Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800652Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800669Adler Instrument CompanyAdler, Inc.GAD2026-10-15
03661219013341LANDANGERLANDANGERGAD2026-10-15
10724995269316Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
10724995269323Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
00190776434953MillenniumAvalign Technologies, Inc.GAD2026-10-14
00192896123922Knurled NutSONTEC INSTRUMENTS, INC.GAD2026-10-14
00190776434632MillenniumAvalign Technologies, Inc.GAD2026-10-12
00190776434663MillenniumAvalign Technologies, Inc.GAD2026-10-12
00190776434700MillenniumAvalign Technologies, Inc.GAD2026-10-12
04058749044249NAFehling Instruments GmbH & Co. KGGAD2026-10-12
G1415189430Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-10-12
00190776434144MillenniumAvalign Technologies, Inc.GAD2026-10-09
00190776434205MillenniumAvalign Technologies, Inc.GAD2026-10-09
00190776434212MillenniumAvalign Technologies, Inc.GAD2026-10-09
00190776434601MillenniumAvalign Technologies, Inc.GAD2026-10-09
00198506095849ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-09
00198506095856ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-09
00840277133717Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133922Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133939Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133946Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133953Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133960Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133977Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133984Innomed, Inc.INNOMED, INC.GAD2026-10-09