FDA.reportPublic FDA data

SANDEL

Primary DI
25414566810147
Brand
SANDEL
Company
Ansell Sandel Medical Solutions LLC
Model
1145
Catalog number
1145
Device description
Z-TRAY, W/ADHESIVE
Published
2022-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
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
35414566810144PackageGS12In Commercial Distribution
25414566810147PrimaryGS10
00071483005295Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3541456681014435414566810144
2541456681014725414566810147
00071483005295000714830052950714830052950071483005295

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, single-useA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure. It is in the form of a shallow receptacle with a raised rim and moulded positions for placing the instruments. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
107961166
Device count
12
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
35414566810045SANDEL2210-N2210-N2022-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
20888277689272MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277688988MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27