FDA.reportPublic FDA data

Strong Manufacturers

Primary DI
10850005354489
Brand
Strong Manufacturers
Company
Strong Medical Partners LLC
Model
5242
Catalog number
5242
Device description
Isolation Gown, AAMI PB70 Level 2, yellow SMS, extra large (XL) size, non-sterile, disposable, open back, over the head, thumb loops, case of 100 each
Published
2022-10-03
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
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850005354489PackageGS1100In Commercial Distribution
00850005354482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000535448910850005354489
00850005354482008500053544828500053544820850005354482

GMDN Terms#

Term, Definition table
TermDefinition
Professional examination gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination procedures to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a single-use garment.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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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10197106810477CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-20
10197106835029CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-19
10197106835128CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-18
10197106720950CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106720974CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721032CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721056CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106746011CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
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10197106785140CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
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10197106829097CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-13
10197106818862CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-05
10197106820759CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-29
10197106741979CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-11
10197106472408CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10197106796115CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10197106743669CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26
10197106744192CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26