FDA.reportPublic FDA data

Strong Manufacturers

Primary DI
10850005354106
Brand
Strong Manufacturers
Company
Strong Medical Partners LLC
Model
8003
Catalog number
8003
Device description
Disposable Underpads - 30" x 30", case of 100 ea
Published
2021-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850005354106PackageGS1100In Commercial Distribution
00850005354109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000535410610850005354106
00850005354109008500053541098500053541090850005354109

GMDN Terms#

Term, Definition table
TermDefinition
Absorbent underpad, non-antimicrobialA flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures, childbirth and/or incontinence; it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Inch
Width30Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
716-507-4476info@strongmanufacturers.com

Regulatory Flags#

DUNS number
062388929
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040791174Strong Manufacturers710171012022-08-19
00810757021056Sam Tell Companies75043NG4PFMD-BK2024-01-12
00810757021063Sam Tell Companies75042NG4PFSM-BK2024-01-12
00810757021070Sam Tell Companies75045NG4PFXL-BK2024-01-12
00810757021049Sam Tell Companies75044NG4PFLG-BK2024-01-12
00810757020899Sam Tell Companies75043NG4PFMD-BK2024-01-12
00810757020905Sam Tell Companies75042NG4PFSM-BK2024-01-12
00810757020912Sam Tell Companies75045NG4PFXL-BK2024-01-12
00810131090609Nception71014GN3042023-11-03
00810131090616Nception71012GN3022023-11-03
00810131090623Nception71013GN3032023-11-03
00810131090630Nception71015GN3052023-11-03
00810131090647Nception71044GN4042023-11-03
00810131090654Nception71042GN4022023-11-03
00810131090661Nception71043GN4032023-11-03
00810131090678Nception71045GN4052023-11-03
00810131090685Nception75042GN402B2023-11-03
00810131090692Nception75043GN403B2023-11-03
00810131090708Nception75044GN404B2023-11-03
00810131090715Nception75045GN405B2023-11-03

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Primary DI, Brand, Company table
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04260647540369TECOtherm Wrabbit +transTec Com Medizintechnik GmbHKME2026-08-26
00199972000535CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
00199972000559CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
00199972000573CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
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00840456206362JMUJMU DENTAL, INCKME2026-07-06
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)Dynarex CorporationKME2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)Dynarex CorporationKME2026-06-08
16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04
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10304040196707Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
10304040196714Henry ScheinHENRY SCHEIN, INC.KME2026-04-17
16931918105475AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-03-18
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCKME2025-11-19