FDA.reportPublic FDA data

Lab Jackets Knitted Cuffs & Collar With Pockets, 2X-Large, White

Primary DI
00616784200620
Brand
Lab Jackets Knitted Cuffs & Collar With Pockets, 2X-Large, White
Company
Dynarex Corporation
Model
2006
Published
2021-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784200637PackageGS13In Commercial Distribution
00616784200620PrimaryGS10
00810180842860Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784200637006167842006376167842006370616784200637
00616784200620006167842006206167842006200616784200620
00810180842860008101808428608101808428600810180842860

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117320925Resp-O2 Incentive Spirometer. Tri-Flow Chamber361022021-04-22
00840117324510Dynarex Bari + Max Bariatric HD Composit Swing Down Rail129542022-11-01
00616784295015Metal Swing Rail129502022-05-09
00616784295114Composite Swing Rail129512022-05-09
00616784295213Q Assist Bar129522022-05-09
00616784295312Pivot Assist Bar129532022-05-09
00616784296012Universal Rotating Assist Bar129602022-05-09
00616784296111Universal Pivot Assist Bar129612022-05-09
00840117303478Expansion Kit for D300129142022-05-09
00840117348578Standard Sling Seat/Back Sling, Mesh10750MS2019-12-30
00840117348592Standard Sling Seat/Back Sling, Canvas10750CN2019-12-30
00840117348615Standard Sling Seat/Back Sling, Mesh With Commode Opening10751MS2019-12-30
00840117348639Standard Sling Seat/Back Sling, Canvas With Commode Opening10751CN2019-12-30
00840117348653Standard Seat/Back Sling - Canvas, Adult Large107522019-12-30
00616784075419Replacement Straps For Standard Slings107542021-04-19
00840117324527Bariatric HD Long-Term Care Bed, DB600, 5 Function Low Bed, Expands to 54"120142022-11-21
00840117302891Long-Term Care Bed, D100120012021-02-03
00840117302907Long Term Care Bed, D200120022021-02-03
00840117302914Long-Term Care Bed D300, 5 Function Low Bed120032021-02-03
00840117302945Bariatric HD Long-Term Care Bed, DB300, 5 Function Low Bed120132021-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456218402JMUJMU DENTAL, INCLYU2026-07-06
00840456218419JMUJMU DENTAL, INCLYU2026-07-06
00840456218426JMUJMU DENTAL, INCLYU2026-07-06
00840456218433JMUJMU DENTAL, INCLYU2026-07-06
00840456218440JMUJMU DENTAL, INCLYU2026-07-06
00840456218457JMUJMU DENTAL, INCLYU2026-07-06
00840456218464JMUJMU DENTAL, INCLYU2026-07-06
00840456218471JMUJMU DENTAL, INCLYU2026-07-06
00840456218488JMUJMU DENTAL, INCLYU2026-07-06
00840456218495JMUJMU DENTAL, INCLYU2026-07-06
00840456220894JMUJMU DENTAL, INCLYU2026-07-06
00840456220900JMUJMU DENTAL, INCLYU2026-07-06
00840456220917JMUJMU DENTAL, INCLYU2026-07-06
00840456220924JMUJMU DENTAL, INCLYU2026-07-06
00840456220931JMUJMU DENTAL, INCLYU2026-07-06
00840456220948JMUJMU DENTAL, INCLYU2026-07-06
00840456220955JMUJMU DENTAL, INCLYU2026-07-06
00840456220962JMUJMU DENTAL, INCLYU2026-07-06
00840456220979JMUJMU DENTAL, INCLYU2026-07-06
00840456220986JMUJMU DENTAL, INCLYU2026-07-06
00840456224328JMUJMU DENTAL, INCLYU2026-07-06
G3731331500Zinnanti SurgicalZinnanti Surgical Design Group IncLYU2026-06-10
00810219420014American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420038American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420052American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420069American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420076American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420083American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00850073571996American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09
00810219420090American Hospital SupplyAmerican Hospital Supply LLCLYU2026-06-09