FDA.reportPublic FDA data

De Mayo Hip Positioner®

Primary DI
00696588004334
Brand
De Mayo Hip Positioner®
Company
Innovative Medical Products, Inc
Model
1101- CASE II LOANER
Catalog number
1101- CASE II LOANER
Device description
Loaner De Mayo Hip Positioner® Case - Second Version
Published
2019-11-07
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
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00696588004334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00696588004334006965880043346965880043340696588004334

GMDN Terms#

Term, Definition table
TermDefinition
Medical capital equipment storage bag/caseA non-sterile, portable, protective container intended to be used by a healthcare provider to store/transport a piece of medical capital equipment (not included) between uses, and may in addition be intended to hold some device components during use; it is not intended to be worn by a patient to hold a personal medical device. It is a durable bag or case with a padded interior intended to prevent damage to medical devices. It is often designed to contain a specific type of device, however it does not include specific parent-device-supportive medical accessories, and is not intended to shield radiation. 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

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