FDA.reportPublic FDA data

Convoluted (Eggcrate) Bed Overlay Pad

Primary DI
00810006684148
Brand
Convoluted (Eggcrate) Bed Overlay Pad
Company
PRIMO INC
Model
ECP72322
Catalog number
ECP72322
Device description
"Convoluted (Eggcrate) Bed Overlay Pad (72"" x 32"" x 2"")"
Published
2021-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ILZAccessories, Traction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILZAccessories, TractionPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810006684145PackageGS112In Commercial Distribution
00810006684148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081000668414510810006684145
00810006684148008100066841488100066841480810006684148

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, single-useA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.

Regulatory Flags#

DUNS number
958758146
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810006680072Glide & Guide Turn Sheet GGS3660GGS36602019-02-27
00810006680089Glide & Guide Turn Sheet GGS3660TSGGS3660TS2019-02-27
00810006680096Glide & Guide Turn Sheet GGS5660GGS56602019-02-27
00810006680355Glide & Guide Turn Sheet Select GGS3660FGGS3660F2019-02-27
00810006680362Glide & Guide Turn Sheet Select GGS3660SSFGGS3660SSF2019-02-27
00810006680379Glide & Guide Turn Sheet GGS3660SSGGS3660SS2019-02-27
00810006680386Glide & Guide Turn Sheet Select GGS3660TSFGGS3660TSF2019-02-27
00810006680393Glide & Guide Turn Sheet GGS4460GGS44602019-02-27
00810006680409Glide & Guide Turn Sheet GGS4460SSGGS4460SS2019-02-27
00810006680416Glide & Guide Turn Sheet GGS4460TSGGS4460TS2019-02-27
00810006680423Glide & Guide Turn Sheet Select GGS5660FGGS5660F2019-02-27
00810006680430Glide & Guide Turn Sheet GGS5660SSGGS5660SS2019-02-27
00810006680447Glide & Guide Turn Sheet Select GGS5660SSFGGS5660SSF2019-02-27
00810006680454Glide & Guide Turn Sheet GGS5660TSGGS5660TS2019-02-27
00810006680461Glide & Guide Turn Sheet Select GGS5660TSFGGS5660TSF2019-02-27
00810006681574Glide & Guide Turn Sheet GGS3660PSGGS3660PS2019-02-27
00810006681598Glide & Guide Turn Sheet GGS5660PSGGS5660PS2019-02-27
00810006682366Synthetic Sheepskin Bed OverlaySS3024SS30242019-02-27
00810006682373Synthetic Sheepskin Bed OverlaySS3040SS30402019-02-27
00810006682380Synthetic Sheepskin Bed OverlaySS3060SS30602019-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888912296533CHATTANOOGADJO, LLCILZ2024-08-20
00630094171470Bioseal Inc.BIOSEALILZ2023-09-18
10630094171477Bioseal Inc.BIOSEALILZ2023-09-18
00630094163604Bioseal Inc.BIOSEALILZ2023-09-13
00630094163635Bioseal Inc.BIOSEALILZ2023-09-13
00630094163642Bioseal Inc.BIOSEALILZ2023-09-13
00630094163659Bioseal Inc.BIOSEALILZ2023-09-13
00630094163666Bioseal Inc.BIOSEALILZ2023-09-13
00630094163727Bioseal Inc.BIOSEALILZ2023-09-13
10630094163601Bioseal Inc.BIOSEALILZ2023-09-13
10630094163632Bioseal Inc.BIOSEALILZ2023-09-13
10630094163649Bioseal Inc.BIOSEALILZ2023-09-13
10630094163656Bioseal Inc.BIOSEALILZ2023-09-13
10630094163663Bioseal Inc.BIOSEALILZ2023-09-13
10630094163724Bioseal Inc.BIOSEALILZ2023-09-13
04260676050082RolkoRolko Kohlgrüber GmbHILZ2023-09-05
04260676050099RolkoRolko Kohlgrüber GmbHILZ2023-09-05
04719871180372EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
04719871180389EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
04719871180396EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
04719871180402EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ILZ2023-08-24
00888912268806CHATTANOOGADJO, LLCILZ2023-04-18
00888912268851CHATTANOOGADJO, LLCILZ2023-04-18
00888912258746CHATTANOOGADJO, LLCILZ2022-12-01
00749756022088DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756022101DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756022118DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756022132DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756022255DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29
00749756097253DeRoyalDEROYAL INDUSTRIES, INC.ILZ2021-07-29