FDA.report

VIVIT Supply

Primary DI
20810141933112
Brand
VIVIT Supply
Company
Vivit Supply LLC
Model
648SL
Device description
Sterilization Wrap, Single Sheet, Purple, V600,48 X 48
Published
2024-10-04
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

Product Codes

CodeName
FRGWrap, Sterilization

Product Code Classifications

CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20810141933112PackageGS11In Commercial Distribution
10810141933115PrimaryGS10
00810141933118Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2081014193311220810141933112
1081014193311510810141933115
00810141933118008101419331188101419331180810141933118

GMDN Terms

TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry, and well ventilated space out of direct sunlight

Sterilization Methods

Method

Regulatory Flags

DUNS number
119042597
Device count
48
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
20810141933792VIVIT Supply201012026-02-26
20810141933808VIVIT Supply201022026-02-26
20810141933815VIVIT Supply201032026-02-26
20810141933822VIVIT Supply201042026-02-26
20810141933839VIVIT Supply201052026-02-26
20810141933877VIVIT Supply708812026-02-25
00810141933880VIVIT Supply708822026-02-25
20810141933891VIVIT Supply708832026-02-25
20810141933907VIVIT Supply708842026-02-25
20810141933914VIVIT Supply708852026-02-25
20810141933747VIVIT Supply205512026-02-03
20810141933754VIVIT Supply205522026-02-03
20810141933761VIVIT Supply205532026-02-03
20810141933778VIVIT Supply205542026-02-03
20810141933785VIVIT Supply205552026-02-03
20810141933488VIVIT Supply1112LJ2025-09-18
20810141933495VIVIT Supply1113LJ2025-09-18
20810141933501VIVIT Supply1114LJ2025-09-18
20810141933518VIVIT Supply1115LJ2025-09-18
20810141933525VIVIT Supply1116LJ2025-09-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00634916099225INSTRUMENT COVERSTANDARD TEXTILE CO., INC.FRG2026-03-11
10810132809986House Brand DentistryFrontier Dental Supply IncFRG2026-02-13
00810194400810AiraAIRA, LLCFRG2026-02-10
00810194400841AiraAIRA, LLCFRG2026-02-10
00810194400858AiraAIRA, LLCFRG2026-02-10
00810194400902AiraAIRA, LLCFRG2026-02-10
00810194400919AiraAIRA, LLCFRG2026-02-10
00810194400926AiraAIRA, LLCFRG2026-02-10
00810194400940AiraAIRA, LLCFRG2026-02-10
00810194400971AiraAIRA, LLCFRG2026-02-10
00810194400995AiraAIRA, LLCFRG2026-02-10
D8305514332MEDICOMAMD Medicom IncFRG2026-02-10
06438263667267Steriking®Wipak OyFRG2026-02-02
06438263667274Steriking®Wipak OyFRG2026-02-02
06438263667281Steriking®Wipak OyFRG2026-02-02
10197344148967MEDLINEMEDLINE INDUSTRIES, INC.FRG2026-01-23
10197344174454MEDLINEMEDLINE INDUSTRIES, INC.FRG2026-01-23
40080196752738MEDLINEMEDLINE INDUSTRIES, INC.FRG2026-01-22
40080196752745MEDLINEMEDLINE INDUSTRIES, INC.FRG2026-01-22
40080196752707MEDLINEMEDLINE INDUSTRIES, INC.FRG2026-01-21
00810194400896AiraAIRA, LLCFRG2026-01-16
00810194400933AiraAIRA, LLCFRG2026-01-16
00810194400964AiraAIRA, LLCFRG2026-01-16
06438263667250Steriking®Wipak OyFRG2025-12-30
06438263620378Steriking®Wipak OyFRG2025-12-30
06438263660640Steriking®Wipak OyFRG2025-12-30
06438263620392Steriking®Wipak OyFRG2025-12-30
06438263620408Steriking®Wipak OyFRG2025-12-30
06438263620415Steriking®Wipak OyFRG2025-12-30
06438263620422Steriking®Wipak OyFRG2025-12-30