FDA.report

UNDERPAD QUILTED IBEX

Primary DI
00634916010459
Brand
UNDERPAD QUILTED IBEX
Company
STANDARD TEXTILE CO., INC.
Model
59755K77
Catalog number
59755K77
Device description
UNDERPAD QUILTED CANADIAN IBEX 33X36 KAUM RM (98 5734) USE: 59750110
Published
2018-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FMWCover, Mattress (Medical Purposes)

Product Code Classifications

CodeDeviceSpecialtyClass
FMWCover, Mattress (Medical Purposes)General Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00634916010459PrimaryGS10
10634916010456Unit of UseGS10
10634916010459Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00634916010459006349160104596349160104590634916010459
1063491601045610634916010456
1063491601045910634916010459

GMDN Terms

TermDefinition
Bed sheet, reusableA large piece of fabric material intended to cover the mattress of a bed to protect it from being soiled and to provide the bed's occupant with clean, non-irritating contact surfaces (over and under). It is typically made of a thin-textile or reinforced-paper material and is laundered for cleaning between periods of use. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-999-0400GUDID@standardtextile.com

Regulatory Flags

DUNS number
006999858
Device count
24
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
00634916019353Standard Supreme966893632026-03-11
00634916099225INSTRUMENT COVER965005122026-03-11
00634916120905Instrument Holder969007152026-03-11
00634916349740Compel MLR OR Gown7567B2162026-03-11
00634916781373WrapPel Table Cover969017842026-03-11
00634916788105Compel MLR OR Gown756747432026-03-11
00634916788112Compel MLR OR Gown756747442026-03-11
00634916788129Compel MLR OR Gown756747452026-03-11
00634916789249ProMax Surgical Gown756747652026-03-11
00634916789256ProMax Surgical Gown,756747642026-03-11
00634916789263ProMax Surgical Gown,756747632026-03-11
00634916792775OR Gown756748362026-03-11
00634916796322ComPel Surgical Gown756566G32026-03-11
00634916796339ComPel Surgical Gown756566G42026-03-11
00634916796346ComPel Surgical Gown756566G52026-03-11
00634916797114Reusable Gown 661YUAG42026-03-11
00634916797121Reusable Gown661YUAG52026-03-11
00634916797459ComPel Isolation Gown6610359V2026-03-11
00634916829358ProMax Surgical Gown756150762026-03-11
00634916870633Instrument Drape966008322026-03-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850045714581Soteria Mattress BarrierTrinity Guardion, Inc.FMW2026-03-10
00840828195898BED COVER-4X36X84-PROGRESSA PULM TOP-PCCURBELL MEDICAL PRODUCTS, INC.FMW2026-01-20
07640178061446CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061736CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061828CT Table CoverPearl Technology AGFMW2025-12-17
07640178061835CT Table CoverPearl Technology AGFMW2025-12-17
07640178061842CT Table CoverPearl Technology AGFMW2025-12-17
07640178061927CT Table CoverPearl Technology AGFMW2025-12-17
07640178061934CT Table CoverPearl Technology AGFMW2025-12-17
07640178061941CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061958CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061965CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061972CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061989CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061996CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062009CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062016CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062023CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062030CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062047CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062054CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062061CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062184CT Table CoverPearl Technology AGFMW2025-12-17
07640178062191CT Table CoverPearl Technology AGFMW2025-12-17
07640178062207CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062214CT Table CoverPearl Technology AGFMW2025-12-17
00850045714536Soteria Neonatal Mattress BarrierTrinity Guardion, Inc.FMW2025-08-18
00840828194433BED COVER 8X36X86 P500 VC STEP DECK - PCCURBELL MEDICAL PRODUCTS, INC.FMW2025-08-11
00818323020403SuresVIVE HEALTH LLCFMW2025-07-09
00818323020410SuresVIVE HEALTH LLCFMW2025-07-09