FDA.reportPublic FDA data

Premium Plus

Primary DI
D8381140WHITE2
Brand
Premium Plus
Company
Premium Plus International Limited
Model
1140-WHITE
Device description
cotton roll dispenser
Published
2020-01-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8381140WHITE8PackageHIBCC20In Commercial Distribution
D8381140WHITE2PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument interim-placement holder, reusableA device intended to be used in the operating room (OR) by staff to safely hold a manual, surgical instrument(s) [e.g., needle, scalpel, scissors] when not in use during surgery, to avoid damage to the instrument, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a reusable device.

Regulatory Flags#

DUNS number
668367758
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D83848982Premium Plus48982020-01-08
D8384604Premium Plus4602019-12-27
D8384704Premium Plus4702019-12-27
D8387460B4Premium Plus7460-B2019-12-27
D8387460G4Premium Plus7460-G2019-12-27
D8387460L4Premium Plus7460-L2019-12-27
D8387460R4Premium Plus7460-R2019-12-27
D8387460Y4Premium Plus7460-Y2019-12-27
D8387470B4Premium Plus7470-B2019-12-27
D8387470G4Premium Plus7470-G2019-12-27
D8387470L4Premium Plus7470-L2019-12-27
D8387470R4Premium Plus7470-R2019-12-27
D8387470Y4Premium Plus7470-Y2019-12-27
D8389062Premium Plus9062019-12-26
D8389072Premium Plus9072019-12-26
D83832202Premium Plus32202020-01-08
D83832252Premium Plus32252020-01-08
D838033LBLUE2Premium Plus033-LBLUE2020-01-08
D8381140BEIGE2Premium Plus1140-BEIGE2020-01-07
D8381140BLUE2Premium Plus1140-BLUE2020-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423841MillenniumAvalign Technologies, Inc.MDM2026-08-26
00190776427641MillenniumAvalign Technologies, Inc.MDM2026-08-26
00810158217409PRINCETONPrinceton Medical Group, Inc.MDM2026-08-25
00850088713626PRINCETONPrinceton Medical Group, Inc.MDM2026-08-25
04054462913602evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913619evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913626evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913909evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913916evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913923evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913947evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913978evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913985evonosevonos GmbH & Co. KGMDM2026-08-25
04054462913992evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914364evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914388evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914395evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914418evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914425evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914814evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914845evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914852evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914906evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914975evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914982evonosevonos GmbH & Co. KGMDM2026-08-25
04054462914999evonosevonos GmbH & Co. KGMDM2026-08-25
04054462915002evonosevonos GmbH & Co. KGMDM2026-08-25
04054462915019evonosevonos GmbH & Co. KGMDM2026-08-25
04054462915026evonosevonos GmbH & Co. KGMDM2026-08-25
04054462915033evonosevonos GmbH & Co. KGMDM2026-08-25