FDA.reportPublic FDA data

SANDEL

Primary DI
25414566810192
Brand
SANDEL
Company
Ansell Sandel Medical Solutions LLC
Model
1151-NS
Catalog number
1151-NS
Device description
"Z-FRICTION DRAPE, 10""X16"" BULK (NS)"
Published
2022-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
35414566810199PackageGS12In Commercial Distribution
25414566810192PrimaryGS10
00071483005165Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3541456681019935414566810199
2541456681019225414566810192
00071483005165000714830051650714830051650071483005165

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray linerA durable foam sheet intended to line the inside of an instrument tray during a surgical procedure to protect delicate or sharp clinical instruments (typically endoscopes or surgical instruments) and prevent instrument movement. It is dedicated for use with an instrument tray and not intended to be used as a drape. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
775-746-6600jacob.ramirez@ansell.com
775-470-7106don.cronk@ansell.com

Regulatory Flags#

DUNS number
107961166
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25414566810147SANDEL114511452022-03-28
25414566810185SANDEL1145-NS1145-NS2022-03-25
25414566810208SANDEL1147-NS1147-NS2022-03-25
25414566810215SANDEL114711472022-03-25
25414566810031SANDEL220422042022-03-28
25414566810048SANDEL2210-N2210-N2022-03-28
25414566810062SANDEL2211-N2211-N2022-03-28
25414566810086SANDEL2215-N2215-N2022-03-28
25414566810109SANDEL2220-N2220-N2022-03-28
25414566810116SANDEL2230-N2230-N2022-03-28
25414566810123SANDEL2231-N2231-N2022-03-28
25414566810130SANDEL2235-N2235-N2022-03-28
25414566810253SANDEL2200-LNS2200-LNS2022-03-28
25414566810260SANDEL2204-NS2204-NS2022-03-28
25414566810277SANDEL2210-NNS2210-NNS2022-03-28
25414566810284SANDEL2211-NNS2211-NNS2022-03-28
25414566810291SANDEL2215-NNS2215-NNS2022-03-28
25414566810307SANDEL2220-NNS2220-NNS2022-03-28
25414566810314SANDEL2230-NNS2230-NNS2022-03-28
35414566810038SANDEL220422042022-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436834MillenniumAvalign Technologies, Inc.MDM2026-10-22
07540277009663RMAC Surgical MarkerRMAC Surgical, IncMDM2026-10-21
00190776435080MillenniumAvalign Technologies, Inc.MDM2026-10-15
00840456225332JMUJMU DENTAL, INCMDM2026-10-13
00840456225349JMUJMU DENTAL, INCMDM2026-10-13
06955045515634hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
06955045515689hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
00190776434120MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776434229MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776433840MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433857MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433673MillenniumAvalign Technologies, Inc.MDM2026-10-07
00190776436162MillenniumAvalign Technologies, Inc.MDM2026-10-07
G141526051160Carnegie Surgical LLCCarnegie Surgical LLCMDM2026-10-07
00190776433536MillenniumAvalign Technologies, Inc.MDM2026-10-06
00190776434311MillenniumAvalign Technologies, Inc.MDM2026-10-06
00810220800584Adler Instrument CompanyAdler, Inc.MDM2026-09-30
00190776432775MillenniumAvalign Technologies, Inc.MDM2026-09-29
00888867618961Arthrex®ARTHREX, INC.MDM2026-09-28
00888867621237Arthrex®ARTHREX, INC.MDM2026-09-28
10888277689251MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689268MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689282MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689299MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689305MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689312MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689329MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689336MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689343MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689350MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28