FDA.report

Bookler Table Mounted Retractor Systems

Primary DI
00842102114649
Brand
Bookler Table Mounted Retractor Systems
Company
FLEXBAR MACHINE CORPORATION
Model
55015
Device description
Tongue Blade, Cruved, Left Side Access
Published
2021-08-18
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

Related Records

Product Codes

CodeName
FFORetractor, Self-Retaining

Product Code Classifications

CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842102114649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842102114649008421021146498421021146490842102114649

GMDN Terms

TermDefinition
Surgical retraction system mounting frame, reusableA noninvasive mounting device (e.g., a large ring, table-fixed bridging bar) designed as a component of a surgical retraction system, intended to be placed/fixed around a surgical incision site and upon which retraction system blades/components are mounted to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during surgery. It does not include the invasive retraction blades/components (i.e., is not the complete system). This is a reusable device.

Sterilization Methods

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 DIBrandModelCatalogPublished
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
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
00842102116278Mini-Bookler Table Mounted Retractor Systems55015-IL2025-07-11
00842102116285Mini-Bookler Table Mounted Retractor Systems55016-IL2025-07-11
00842102116292Mini-Bookler Table Mounted Retractor Systems55017-IL2025-07-11
00842102116308Mini-Bookler Table Mounted Retractor Systems55018-IL2025-07-11
00842102116247StrongArm Surgical Holders and Positioners73001-SA-LP2025-05-05
00842102116230Flexarm Surgical Holders and Positioners38048-22025-04-29
00842102116193Bookler Table Mounted Retractor Systems758142025-04-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00842102116421Bookler Table Mounted Retractor SystemsFLEXBAR MACHINE CORPORATIONFFO2026-03-19
09348811023667INKAThe Trustee for KAISER FAMILY TRUSTFFO2026-03-16
00192896122765Balfour Deluxe RetractorSONTEC INSTRUMENTS, INC.FFO2026-03-10
B382SD4942000Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942010Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942020Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942030Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942040Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942050Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942060Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942070Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942080Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942090Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942100Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942110Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942120Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942130Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942140Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942150Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942160Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942170Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942180Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942190Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942200Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942210Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD494222Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD494223Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942240Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942250Surgical DirectSurgical Direct, Inc.FFO2026-03-02
B382SD4942260Surgical DirectSurgical Direct, Inc.FFO2026-03-02