FDA.report

Disposable Scrub Pants

Primary DI
00616784196534
Brand
Disposable Scrub Pants
Company
DYNAREX CORPORATION
Model
1965
Device description
Disposable Scrub Pants, Tie Waist, Small, Light Blue
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
OEANon-Surgical Isolation Gown

Product Code Classifications

CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784196534PackageGS130In Commercial Distribution
00616784196527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784196534006167841965346167841965340616784196534
00616784196527006167841965276167841965270616784196527

GMDN Terms

TermDefinition
Scrub suit, single-useA two-piece garment designed to be worn by healthcare staff to facilitate hygienic conditions typically in areas where surgery is performed. It typically consists of a shirt and pants composed of disposable materials and is intended to provide a barrier to help prevent cross-contamination of infectious agents between staff and patients. This is a single-use garment.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
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 DIBrandModelCatalogPublished
00810180843331Durma+ DynaRule Disposable Paper Rulers30062026-03-24
00810180845106Cotton Tipped Wood Applicators, Sterile43042022-04-22
00810180845113Cotton Tipped Wood Applicators, Sterile43052022-04-22
00810180840712CurPro Dermal Curettes,2 mm 41552024-12-16
00840117347892Medi-Cut Safety Scalpel41652022-04-17
00810180844901Disposable Prep Razors42512020-11-02
00810180844918Medicine Cups 1oz 42522024-10-28
00810180844925LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Ever Seal 42542021-06-21
00810180844703Bandage Shears 7.5" Orange4183-BX2020-11-08
00810180844710Bandage Shears 7.5" Purple4184-BX2020-11-08
00810180844840Emesis Basin42242022-05-02
00810180844857Sitz Bath42282021-09-01
00810180844864Urinal- Male42292021-09-01
00810180844871Bed Pans42302021-04-22
00810180844888Bed Pans42312021-04-22
00810180844895Nuns Cap Specimen Collector42322021-04-22
00840117331822DynaSafety Heavy Duty Woven Fabric Knuckle Bandages, 1 1/2" x 3"3765BULK2024-03-08
00840117331853DynaSafety Heavy Duty Woven Fabric Bandages, Large Patch, 2" x 3"3766BULK2024-03-08
00840117331907DynaSafety Heavy Duty Woven Fabric Bandages, Sterile, 7/8" x 3"3767BULK2024-03-08
00840117350045Pill Crusher Pouch42102021-09-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10080196163885MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
10884389110003MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
10884389110010MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
10884389110072MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-24
00634916797114Reusable Gown STANDARD TEXTILE CO., INC.OEA2026-03-11
00634916797121Reusable GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916797459ComPel Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916881356Reversible Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
00634916881363Reversible Isolation GownSTANDARD TEXTILE CO., INC.OEA2026-03-11
10810132044356HCSConcordance Healthcare Solutions LLCOEA2026-03-09
20810132044360HCS SourcingConcordance Healthcare Solutions LLCOEA2026-03-09
40080196765523MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-05
10197344158881MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158904MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158928MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158942MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158966MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344158997MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159000MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159024MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159031MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159048MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159055MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159062MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159079MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159086MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159093MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159116MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344159123MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03
10197344200474MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-03-03