FDA.reportPublic FDA data

PremierPro

Primary DI
10818566017410
Brand
PremierPro
Company
SVS LLC
Model
8994
Catalog number
8994
Device description
Cohesive Bandage, Non-Sterile, 4" x 5" Stretched, Blue, 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQMBandage, Elastic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQMBandage, ElasticGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818566017410PackageGS118In Commercial Distribution
00818566017413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081856601741010818566017410
00818566017413008185660174138185660174130818566017413

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid Direct Sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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 DI, Brand, Model table
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 DI, Brand, Company table
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