FDA.reportPublic FDA data

HOLYMED

Primary DI
06973071239027
Brand
HOLYMED
Company
Changzhou HolyMED Products Co.,Ltd.
Model
HL3660SBM
Device description
LAB COAT/LAB JACKET
Published
2022-07-29
Public version status
New
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
06973071239027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973071239027069730712390276973071239027

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
559978934
Device count
1
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
06973071239003HOLYMEDHL3660SBXS2022-07-29
06973071239010HOLYMEDHL3660SBS2022-07-29
06973071239034HOLYMEDHL3660SBL2022-07-29
06973071239041HOLYMEDHL3660SBXL2022-07-29
06973071239058HOLYMEDHL3660SB2XL2022-07-29
06973071239065HOLYMEDHL3660SB3XL2022-07-29
06973071239072HOLYMEDHL3660SB4XL2022-07-29
06973071239089HOLYMEDHL3660SB5XL2022-07-29
06973071239140HOLYMEDHLS3660WHXL2022-07-29
06973071239201HOLYMEDHL3660WHXS2022-07-29
06973071239218HOLYMEDHL3660WHS2022-07-29
06973071239225HOLYMEDHL3660WHM2022-07-29
06973071239232HOLYMEDHL3660WHL2022-07-29
06973071239249HOLYMEDHL3660WHXL2022-07-29
06973071239256HOLYMEDHL3660WH2XL2022-07-29
06973071239263HOLYMEDHL3660WH3XL2022-07-29
06973071239270HOLYMEDHL3660WH4XL2022-07-29
06973071239287HOLYMEDHL3660WH5XL2022-07-29
06973071239508HOLYMEDHLS3650EGXS2022-07-29
06973071239515HOLYMEDHLS3650EGS2022-07-29

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