FDA.reportPublic FDA data

Exact-Fit™ De Mayo Lateral Positioner™

Primary DI
00696588006338
Brand
Exact-Fit™ De Mayo Lateral Positioner™
Company
Innovative Medical Products, Inc
Model
617-LS
Catalog number
617-LS
Device description
Exact-Fit™ Adjustable Lateral Support Arm
Published
2020-08-26
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
FWZOperating Room Accessories Table Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00696588006338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00696588006338006965880063386965880063380696588006338

GMDN Terms#

Term, Definition table
TermDefinition
Torso intraoperative positionerA preformed device (e.g., cushion, foam pad, lateral post, bolster, wedge) designed to be attached to an operating table for stabilizing a patient's body trunk (e.g., chest, pelvis, hips) to adequately position, support, and reduce pressure on the bony prominences of the body part during intraoperative procedures (e.g., orthopaedic surgery). It is typically used when the patient is in the prone or lateral position; components for attachment to the operating table (e.g., adaptors, straps) may be included. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
147363154
Device count
1
DM exempt
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00696588008189HipFit-ULP™325-BP325-BP2025-10-15
00696588008196HipFit-ULP™325-LB325-LB2025-10-15
00696588008202HipFit-ULP™325-AN325-AN2025-10-15
00696588008219HipFit-ULP™325-KIT325-KIT2025-10-17
00696588008226HipFit-ULP™325-SYS KIT325-SYS KIT2025-10-17
00696588008257De Mayo Universal Distractor®621AS621AS2026-01-20
00696588008240De Mayo Adapt2Fit® Modular Knee Positioner 1020-923-717-SYS KIT LOANER1020-923-717-SYS KIT LOANER2025-12-16
00696588008165De Mayo Adapt2Fit® Modular Knee Positioner 1020-LRP1020-LRP2025-09-17
00696588008172De Mayo Adapt2Fit® Modular Knee Positioner 1020-UPGRADE KIT1020-UPGRADE KIT2025-09-17
00696588008141De Mayo Adapt2Fit® Modular Knee Positioner 1020-PRK1020-PRK2025-08-28
00696588008158De Mayo Adapt2Fit® Modular Knee Positioner 1020-PRKD1020-PRKD2025-08-28
00696588008127De Mayo D2® Knee Positioner®803-114-923-A713-7803-114-923-A713-72025-08-18
00696588008134De Mayo D2® Knee Positioner®803-114-923-A713-7-P803-114-923-A713-7-P2025-08-18
00696588008110De Mayo Universal Distractor®907AS907AS2025-08-11
00696588008073De Mayo Knee Positioner®114-TP114-TP2025-08-05
00696588008080De Mayo Knee Positioner®803-631803-6312025-08-05
00696588008097De Mayo D2® Knee Positioner®803-114-923S KIT803-114-923S KIT2025-07-28
00696588008103De Mayo D2® Knee Positioner®803-114-923S KIT-P803-114-923S KIT-P2025-07-28
00696588008066De Mayo Adapt2Fit® Modular Knee Positioner 1020-PCT1020-PCT2025-06-30
00696588008035Exact-Fit® De Mayo Lateral Positioner®617-47617-472025-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260217222176AMTRION Claw 4025Amtrion GmbHFWZ2026-05-26
00696588008257De Mayo Universal Distractor®Innovative Medical Products, IncFWZ2026-01-20
10653405986362CONMEDConmed CorporationFWZ2026-01-17
30653405986373CONMEDConmed CorporationFWZ2026-01-17
20653405990182CONMEDConmed CorporationFWZ2026-01-17
00696588008240De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-12-16
00696588008165De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-09-17
00696588008172De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-09-17
00696588008141De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-08-28
00696588008158De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-08-28
00696588008127De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2025-08-18
00696588008134De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2025-08-18
00696588008110De Mayo Universal Distractor®Innovative Medical Products, IncFWZ2025-08-11
00696588008073De Mayo Knee Positioner®Innovative Medical Products, IncFWZ2025-08-05
00696588008080De Mayo Knee Positioner®Innovative Medical Products, IncFWZ2025-08-05
00696588008097De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2025-07-28
00696588008103De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2025-07-28
00696588008066De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-06-30
00696588008035Exact-Fit® De Mayo Lateral Positioner®Innovative Medical Products, IncFWZ2025-06-04
00696588008042Exact-Fit® De Mayo Lateral Positioner®Innovative Medical Products, IncFWZ2025-06-04
00696588008059Exact-Fit® De Mayo Lateral Positioner®Innovative Medical Products, IncFWZ2025-06-04
00696588008028MorphBoard®Innovative Medical Products, IncFWZ2025-05-28
00696588007960MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588007977MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588007984MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588007991MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588008004MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588008011MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00724995245016ClampSTERIS CORPORATIONFWZ2025-05-05
00696588007922UKnee Suspended Knee PositionerInnovative Medical Products, IncFWZ2025-04-09