FDA.reportPublic FDA data

Barrier Film

Primary DI
00616784448831
Brand
Barrier Film
Company
DYNAREX CORPORATION
Model
4488
Device description
Barrier Film, Clear, 4"x6", 1200 sheets per roll
Published
2021-06-21
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

Product Codes#

Code, Name table
CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784448831PackageGS18In Commercial Distribution
00616784448824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784448831006167844488316167844488310616784448831
00616784448824006167844488246167844488240616784448824

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray corner protector, single-useA device designed to cover the sharp corners of an instrument tray before the tray is wrapped with sterilization packaging (wrap), to protect the wrap from tearing and the tray corners from damage. It is typically made of synthetic polymer materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117305274Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500301012021-04-22
00840117305298Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000301032021-04-22
00840117305656Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500301002021-04-22
00840117305847Resp-O2 Heat Moisture Exchanger + Filter (HMEF) 1500301022021-04-22
00840117307728Ever-Soft Positioning Wedge130012021-04-22
00840117307742Ever-Soft Positioning Wedge130022021-04-22
00840117307766Ever-Soft Positioning Wedge130032021-04-22
00840117321045Bari+Max Bariatric Gel Foam Wheelchair Cushion 24"x18"x3"130542021-04-22
00840117321052Bari+Max Bariatric Gel Foam Wheelchair Cushion 26"x20" "x3"130552021-04-22
00840117321090Bari+Max Bariatric Gel/Foam Cushion 22"x18"x3"130502021-04-22
00840117321106Bari+Max Bariatric Gel/Foam Cushion 24"x18"x3"130512021-04-22
00616784304113Dmecare Solutions Solid Seat Insert13041-162021-09-01
00616784304212DMECare Solutions Solid Seat Insert13041-182021-09-01
00616784304311DMECare Solutions Solid Seat Insert13041-202021-09-01
00616784304410DMECare Solutions Solid Seat Insert13041-222021-09-01
00616784304519DMECare Solutions Solid Seat Insert13041-242021-09-01
00840117321021Bariatric Reclining Wheelchair 24" with Elevating Leg Rest15015-24DELR2024-05-08
00840117321168DynaRide Pediatric Wheelchair with Footrest 12"15009-12DFR2024-05-09
00840117321175DynaRide Pediatric Wheelchair with Footrest 14"15009-14DFR2024-05-09
00840117322684Bariatric Reclining Wheelchair 26" with Elevating Leg Rest15015-26DELR2024-05-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840456223284JMUJMU DENTAL, INCNRD2026-07-08
00840456223291JMUJMU DENTAL, INCNRD2026-07-08
00840456223314JMUJMU DENTAL, INCNRD2026-07-08
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