FDA.reportPublic FDA data

SLEEVE

Primary DI
00840186696259
Brand
SLEEVE
Company
BURLINGTON MEDICAL, LLC
Model
U8SL3-MD
Device description
Sleeve - Slip On .25mm Xenolite 800 NL Size Medium
Published
2022-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IWOApron, Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWOApron, ProtectiveRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840186696259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840186696259008401866962598401866962590840186696259

GMDN Terms#

Term, Definition table
TermDefinition
Surgical sleeve coverA forearm covering made of non-woven synthetic fabric materials intended to be worn over a scrub suit by healthcare staff during a surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083381202
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197513012597TABLEPADAM3085-Q1.5-DBCBVHLA2024-11-22
00197513011958TABLEPADSK3100-Q1.5-DBCBVHLA2024-10-21
00197513011965TABLEPADSK3100-T2.5-DBCBVHLA2024-10-21
00197513011972TABLEPADSK3100-T3-DBCBVHLA2024-10-21
00197513011989TABLEPADAM3080-Q1.5-DBCBVHLA2024-10-21
00197513011996TABLEPADAM3080-T2.5-DBCBVHLA2024-10-21
00197513012009TABLEPADAM3080-T3-DBCBVHLA2024-10-21
00197513012016TABLEPADAM3085-T1.5-DBCBVHLA2024-10-21
00197513012023TABLEPADAM3085-T2.5-DBCBVHLA2024-10-21
00197513012030TABLEPADAM3085-T3-DBCBVHLA2024-10-21
00197513012047TABLEPADSH4900-Q1.5-DBCBVHLA2024-10-21
00197513012054TABLEPADSH4900-T2.5-DBCBVHLA2024-10-21
00197513012061TABLEPADSH4900-T3-DBCBVHLA2024-10-21
00197513012078TABLEPADSK3600-Q1.5-DBCBVHLA2024-10-21
00197513012085TABLEPADSK3600-T2.5-DBCBVHLA2024-10-21
00197513012092TABLEPADSK3600-T3-DBCBVHLA2024-10-21
00197513012108TABLEPADSK6700-Q1.5-DBCBVHLA2024-10-21
00197513012115TABLEPADSK6700-T2.5-DBCBVHLA2024-10-21
00197513012122TABLEPADSK6700-T3-DBCBVHLA2024-10-21
00197513012139TABLEPADSK6701-Q1.5-DBCBVHLA2024-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G242TC3N90Techno-AideTechno-Aide, Inc.IWO2025-12-22
00817169029380Visionary By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCIWO2025-12-16
G309SG20Stevens-MoonStevens-Moon Sales Professionals LLCIWO2025-05-21
G242J23N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242J25N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JL3N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JL5N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JM3N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JX3N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JX5N90Techno-AideTechno-Aide, Inc.IWO2024-11-14
G242JM5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242JP3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242JP5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242JS3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242JS5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242K23N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242K25N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KL3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KL5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KM3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KM5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KP3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KP5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KS3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KS5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KX3N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
G242KX5N90Techno-AideTechno-Aide, Inc.IWO2024-11-13
00197513011897Thyroid Shield BATBURLINGTON MEDICAL, LLCIWO2024-08-26
00197513011903Thyroid Shield BATBURLINGTON MEDICAL, LLCIWO2024-08-26
00197513011910Thyroid Shield BATBURLINGTON MEDICAL, LLCIWO2024-08-26