FDA.report

PremierPro

Primary DI
10811220032569
Brand
PremierPro
Company
SVS LLC
Model
8192
Catalog number
8192
Device description
CHOICE Cohesive Bandage, Non-Sterile, 2" Blue, 2"x5yards Stretched, Not made with Natural Rubber Latex
Published
2020-08-29
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
true

Related Records

Contact Domains

Product Codes

CodeName
FQMBandage, Elastic

Product Code Classifications

CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10811220032569PackageGS136In Commercial Distribution
00811220032562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081122003256910811220032569
00811220032562008112200325628112200325620811220032562

GMDN Terms

TermDefinition
Non-adhesive device retention bandageA piece or roll of material intended to be wrapped around a part of the body to secure a device (e.g., skin dressing, catheter, cannula) to the patient, without adhering to or compressing the body. It may be made from a variety or combination of materials, including cotton, viscose, and plastic (e.g., polyamide), and some types are cohesive (i.e., the bandage adheres to itself but not to other surfaces); it is used in various clinical specialties (e.g., dermatology, general/plastic surgery). This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Avoid Direct Sunlight

Sterilization Methods

Method

Contacts

PhoneEmail
1-855-531-7699udi@s2s-global.com

Regulatory Flags

DUNS number
831375089
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00811220035495PremierPro882088202024-10-28
00811220035518PremierPro882188212024-10-28
10811220035430PremierProD5061D50612024-03-08
10811220035447PremierProD5062D50622024-03-08
10811220035454PremierProD5063D50632024-03-08
10811220035461PremierProD5064D50642024-03-08
10811220035478PremierProD5065D50652024-03-08
00811220035143PremierProFL1003DFL1003D2024-02-14
00811220035174PremierProFL1005DFL1005D2024-02-14
00811220035099PremierProFL1010DFL1010D2024-02-14
00811220035112PremierProFL1010SFFL1010SF2024-02-14
00811220034412PremierPro™31T1417531T141752022-12-19
00811220034443PremierPro™31T1617731T161772022-12-19
00811220034474PremierPro™31T1811631T181162022-12-19
00811220034504PremierPro™31T1818831T181882022-12-19
00811220034535PremierPro™31T2011631T201162022-12-19
00811220034566PremierPro™31T2010031T201002022-12-19
00811220034597PremierPro™31T2018831T201882022-12-19
00811220034627PremierPro™31T2210031T221002022-12-19
00811220034658PremierPro™31T2407531T240752022-12-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810178881192Dr PatsVIVE HEALTH LLCFQM2026-02-05
00810178881208Dr PatsVIVE HEALTH LLCFQM2026-02-05
00810178884599ViveCareVIVE HEALTH LLCFQM2026-02-05
00810178884605ViveCareVIVE HEALTH LLCFQM2026-02-05
00810178884612ViveCareVIVE HEALTH LLCFQM2026-02-05
08809302580652New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580683New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580928New Soosung Elastic Bandagesoosung medicalFQM2025-12-26
08809302580874New Soosung Elastic Bandagesoosung medicalFQM2025-12-24
08809302587538Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587545Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587552Soosung Elastic Bandagesoosung medicalFQM2025-12-11
08809302587569Soosung Elastic Bandagesoosung medicalFQM2025-12-11
00029369186019McDavidDoctor Shock IncFQM2025-12-01
00029369186026McDavidDoctor Shock IncFQM2025-12-01
26975803530802GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530819GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530826GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530833GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530840GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530857GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
26975803530864GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
16975803530874GSOGroup Supply Organization Medical Technology(Shanghai) LtdFQM2025-11-30
30840330705869ProCureTwin Med, LLCFQM2025-11-26
30840330705876ProCureTwin Med, LLCFQM2025-11-26
30840330705883ProCureTwin Med, LLCFQM2025-11-26
04250381827123Head bandageSpiggle & Theis Medizintechnik GmbHFQM2025-09-19
04250381827130Head bandageSpiggle & Theis Medizintechnik GmbHFQM2025-09-19
04250381827147Elastic head bandage with ear slipSpiggle & Theis Medizintechnik GmbHFQM2025-09-19
50192253065280CARDINAL HEALTHCardinal Health 200, LLCFQM2025-09-15