FDA.reportPublic FDA data

NA

Primary DI
23596010468837
Brand
NA
Company
Smith & Nephew, Inc.
Model
7209468
Catalog number
7209468
Device description
BOOTS FL BARRIER LG 50 PAIRS CS
Published
2015-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

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
23596010468837PackageGS1100In Commercial Distribution
03596010468833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2359601046883723596010468837
03596010468833035960104688333596010468833

GMDN Terms#

Term, Definition table
TermDefinition
Waterproof shoe coverA device made of a waterproof material intended to be used as a physical barrier on a shoe to protect the shoe from liquid contamination. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
109903521
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556919712Real IntelligenceROB30001ROB300012026-03-10
00885556919729Real IntelligenceROB30002ROB300022026-03-10
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919750Real IntelligenceROB30004ROB300042026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
00885556919774Real IntelligenceROB30006ROB300062026-03-10
00885556924198Real IntelligenceROB30026ROB300262026-03-10
00885556924204Real IntelligenceROB30021ROB300212026-03-10
00885556924211Real IntelligenceROB30027ROB300272026-03-10
00885556924228Real IntelligenceROB30022ROB300222026-03-10
00885556924235Real IntelligenceROB30023ROB300232026-03-10
00885556924242Real IntelligenceROB30024ROB300242026-03-10
00885556924266Real IntelligenceROB30028ROB300282026-03-10
00885556924273Real IntelligenceROB30020ROB300202026-03-10
00885556924297Real IntelligenceROB30880ROB308802026-03-10
20885556924307NAROB30031ROB300312026-03-10
00885556787786NA74034136740341362026-02-20
00885556884027NA74038834740388342026-02-20
00885556884034NA74038835740388352026-02-20
00885556884140NA74038846740388462026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810219420120American Hospital SupplyAmerican Hospital Supply LLCLYU2026-03-11
00810219420090American Hospital SupplyAmerican Hospital Supply LLCLYU2026-03-10
00810219420113American Hospital SupplyAmerican Hospital Supply LLCLYU2026-03-10
08057147052111MDU7023S UNIVET SRLLYU2026-03-02
G1493806305TBS DentalACME ENTERPRISE.LYU2026-03-02
G149TBSMH107TBS DentalACME ENTERPRISE.LYU2026-03-02
10810132043731HCSConcordance Healthcare Solutions LLCLYU2026-01-16
20810141933488VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933495VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933501VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933518VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933525VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933532VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933549VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933556VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933563VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933570VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933587VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933594VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933600VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933617VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933624VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933631VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933648VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933655VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933662VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933679VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933686VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933693VIVIT SupplyVivit Supply LLCLYU2025-09-18
20810141933709VIVIT SupplyVivit Supply LLCLYU2025-09-18