FDA.reportPublic FDA data

SANDEL

Primary DI
25414566810154
Brand
SANDEL
Company
Ansell Sandel Medical Solutions LLC
Model
1151
Catalog number
1151
Device description
"Z-FRICTION DRAPE, 10""X16"""
Published
2022-03-25
Public version status
New
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
35414566810151PackageGS12In Commercial Distribution
25414566810154PrimaryGS10
00071483005158Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3541456681015135414566810151
2541456681015425414566810154
00071483005158000714830051580714830051580071483005158

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.

Contacts#

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

Regulatory Flags#

DUNS number
107961166
Device count
40
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
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
10888277688988MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689190MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689206MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689213MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689220MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689237MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689244MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
20888277688978MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10080196320899MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321407MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321414MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321438MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321452MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321469MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321476MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321483MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321490MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10888277689183MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321445MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-24
00190776431587MillenniumAvalign Technologies, Inc.MDM2026-09-22
00850088713886PRINCETONPrinceton Medical Group, Inc.MDM2026-09-22
00850088713893PRINCETONPrinceton Medical Group, Inc.MDM2026-09-22
00888867574489Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574496Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574502Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574519Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574526Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574533Arthrex®ARTHREX, INC.MDM2026-09-18
10888277688896MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688902MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18