FDA.reportPublic FDA data

SLEEVE

Primary DI
00840186623903
Brand
SLEEVE
Company
BURLINGTON MEDICAL, LLC
Model
SESL3-MD
Device description
Sleeve - Slip On .35mm Enviro-Lite Size Medium
Published
2022-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840186623903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840186623903008401866239038401866239030840186623903

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.

Regulatory Flags#

DUNS number
083381202
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197513011903Thyroid Shield BATR5BATH2024-08-26
00197513011910Thyroid Shield BATR5BATB2024-08-26
00197513011934Thyroid Shield BATR8BATH2024-08-26
00197513011941Thyroid Shield BATR8BATB2024-08-26
00197513012597TABLEPADAM3085-Q1.5-DBCBVHLA2024-11-22
00197513012016TABLEPADAM3085-Q1.5-DBCBVHLA2024-10-21
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G031VBO2XFNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XFTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBO2XMTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLFTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOLMTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFNLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFRL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFRLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFTL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMFTLL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13
G031VBOMMNL0Vest Only w/ BeltShielding International Inc.IWO2026-07-13